US Market News
2週前
In the Ebola Emergency, NV-387 is Ready to be Shipped to DRC, and It Compares Favorably as a Treatment for Ebola Versus Possible Options, Says NanoViricidesMay 26, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 26, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, compares potential treatment options for Ebola Bundibugyo virus strain and finds that the Company's broad-spectrum antiviral drug candidate NV-387 is worthy of evaluation in this scenario.The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[1], such as fruit bats.The outbreak which was declared a public health emergency of international concern by the WHO on May 16, 2026, is rapidly expanding, outpacing containment efforts, with over 900 suspected cases and over 220 deaths, in a high traffic region bordering the Democratic Republic of Congo (DRC), Uganda, and South Sudan and with 11 more nations in Africa at risk[2].There are no approved vaccines or treatments against the Bundibugyo virus.As such, the possible treatment options during the current expanding outbreak scenario must look at either other approved therapies that may not work, or look at new therapies that are at clinical stage.There were four drug candidates tested in a clinical trial in an Ebola Zaire outbreak, namely an antibody cocktail called ZMapp, another antibody cocktail called REGN-EB3, a monoclonal antibody developed from a survivor patient called mAb114, and a broad-spectrum nucleotide analog drug called Remdesivir. Of these, the more effective mAb114 (Ebanga) and REGN-EB3 (Inmazeb) were approved as treatments for Ebola Zaire infection, and the effect of ZMapp and Remdesivir against standard of care was not evaluated in the PALM clinical trial[3].All of these four drugs require infusions, which is very difficult in a deadly disease such as Ebola that requires strong patient isolation protocols, and wherein protection of health care workers is of utmost important. Further, monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.Recently, a drug candidate, obeldesivir, was developed related to remdesivir[4]. Oral obeldesivir failed as a treatment for COVID-19 in a Phase III clinical trial[5].This clinical failure raises substantial doubts that obeldesivir would be of any benefit in Ebola Bundibugyo infection, since the clinical activity of obeldesivir indeed appears to be less than that of remdesivir, Remdesivir was approved for COVID-19, but not for Ebola Zaire.NV-387 was previously evaluated by the Company in animal models wherein a separate group of infected animals was treated with remdesivir to serve as a positive control. The increase in survival over untreated animals was 8.5 days (170%) for NV-387 IV, 4.4 days (88%) for NV-387 Oral, but only 2 days (40%) for Remdesivir IV in this uniformly lethal infection model for COVID-19[6]. This indicates that NV-387 IV as well as NV-387 PO were substantially superior to Remdesivir.We believe these results of NV-387 being superior to Remdesivir as a treatment would hold for other viruses as well, including Ebola viruses.NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments."We believe NV-387 could be effective against the Bundibugyo strain of Ebola that is spreading rapidly in Africa," said Anil R. Diwan, PhD, adding, "All filoviruses including all Ebola strains utilize the sulfated proteoglycans for initial cell attachment; which is the feature that NV-387 presents to the viruses to destroy them."NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.NV-387 Oral Gummies drug product is ready to be shipped to DRC for the impending Phase II clinical trial of NV-387 as a Treatment for Mpox. It will thus be immediately locally available to combat the Ebola outbreak if it shows effectiveness against Ebola Bundibugyo in patients.If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[7]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.The WHO declared a Public Health Emergency of International Concern (PHEIC) for the Bundibugyo outbreak in Eastern DRC, with two cases in Uganda in travelers from Congo, on May 17, 2026[8]. The outbreak itself was declared on May 15, although the initial or "patient zero" case likely occurred in April, 2026. This delay was primarily because of the cases occurring in clusters in multiple remote locations that had limited reporting capabilities.Some Americans currently in DRC have been affected. It is not clear if they have been traced as contacts, or have acquired infection awaiting diagnosis. The US CDC with other US departments is active in extracting Americans exposed to ebolavirus and moving them into an isolated area for treatment, as necessary[9].The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially. Currently there is no apparent threat of a pandemic.With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus. Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic."Only safe and effective broad-spectrum antiviral drugs that can effectively combat most viral infections will enable the world to combat viruses and defend the global population in the war against known and unknown nanoscopic enemies that are viruses," commented Dr. Diwan, adding, "NV-387 is the only drug with such potential that is in clinical development today, to the best of our knowledge."ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com[1] https://virological.org/t/initial-genomes-from-may-2026-bundibugyo-virus-disease-outbreak-in-the-democratic-republic-of-the-congo-and-uganda/1032[2] https://www.forbes.com/sites/maryroeloffs/2026/05/25/african-health-officials-on-ebola-this-is-too-much-live-updates/[3] Prasad, AN, Woolsey, C., Borisevich, V., Agans, KN, Deer, DJ, Geisbert, JB, Harrison, MB, Dobias, NS, Karla A. Fenton, KA, Robert W. Cross, RW & Geisbert, TW. "Remdesivir, mAb114, REGN-EB3, and ZMapp partially rescue nonhuman primates infected with a low passage Kikwit variant of
Ebola virus." Nature Communications (2025)16:3824.[4] Obeldesivir is an oral prodrug of a metabolite of remdesivir called GS-441524, i.e. Obeldesivir converts to GS-441524, which then converts to its phosphate form that is the same active moiety as formed from remdesivir itself. However, GS-441524 was known to be substantially less active compared to remdesivir.[5] Lancet Infect Dis 2025; 25: 1282-92, https://doi.org/10.1016/S1473-3099(25)00238-5.[6] We developed a BSL-2 uniformly lethal animal model (rat) for COVID-19 by using hCoV-NL63 infection. NL63 uses the same receptor ACE2 as SARS-CoV-2. Additionally, all coronaviruses use HSPG as the initial attachment receptor. Untreated and Vehicle treated animals in this study died uniformly on day 5.[7] Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.[8] https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern[9] https://www.statnews.com/2026/05/17/ebola-outbreak-congo-americans-exposure-suspected-cases/SOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: In the Ebola Emergency, NV-387 is Ready to be Shipped to DRC, and It Compares Favorably as a Treatment for Ebola Versus Possible Options, Says NanoViricides
US Market News
3週前
NanoViricides Announces Closing of ~$2 Million Registered Direct OfferingMay 18, 2026 11:55 PM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 18, 2026 / NanoViricides, Inc. (NYSE American:NNVC) ("NanoViricides" or the "Company"), a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape, today announced the closing of its previously announced registered direct offering (the "Offering") of 1,333,334 million shares of common stock (or pre-funded warrants in lieu thereof), together with accompanying warrants to purchase 1,333,334 common shares (the "Offering"). The Offering was made to a single, fundamental institutional investor and priced at-the-market price of US$1.50 for each common share and accompanying whole warrant to purchase one common share. Each whole warrant has an exercise price of US$1.75 per share and will be exercisable six months from issuance and will expire in three years. The Company received aggregate gross proceeds of $2,000,001 from the Offering, before deducting placement agent fees and other related expenses.D. Boral Capital LLC acted as the exclusive placement agent for the Offering.The ordinary shares (or pre-funded warrants in lieu thereof) were offered by the Company pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333- 271706), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on May 22, 2023.A prospectus supplement describing the terms of the proposed registered direct offering was filed with the SEC and is available on the SEC's website at https://www.sec.gov/. A copy of the prospectus supplement and accompanying base prospectus relating to the offering may be obtained, when available, from D. Boral Capital LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, or by telephone at (212) 404-7002, or by email at dbccapitalmarkets@dboralcapital.com.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About NanoViricidesNanoViricides, Inc., is a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape. Its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an "Orphan Drug Designation" (ODD) by the US FDA Office of Orphan Products Development (OOPD). This could provide 7 years market exclusivity, tax credits for clinical trial costs, and fee exemptions upon approval. NV-387 is a revolutionary antiviral that we believe will be the drug offered at "first visit" when the patient presents to a doctor with any respiratory viral illness. NV-387 was also found to be highly effective in lethal animal infection models of Influenza, RSV, Coronaviruses, Monkeypox, Smallpox, and Measles.Forward-Looking StatementsStatements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the use of words such as "may," "will," "plan," "should," "expect," "anticipate," "estimate," "continue," or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends, and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate and involve factors that may cause actual results to differ materially from those projected or suggested. These risks include, but are not limited to, the ability to complete the offering on the terms described or at all, the ability to satisfy customary closing conditions, market conditions, regulatory developments affecting the digital asset and stablecoin industries, and other risks described in the Company's filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading "Risk Factors" in the Company's Annual Reports on Form 20-F, as may be supplemented or amended by the Company's Reports of a Foreign Private Issuer on Form 6-K. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information, or otherwise.ContactsFor Inquiries, Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.comSource: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: NanoViricides Announces Closing of ~$2 Million Registered Direct Offering
US Market News
3週前
Ebola Global Health Emergency Needs a Broad-Spectrum Drug - NV-387 is a Strong Potential Candidate, Says NanoViricidesMay 18, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 18, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, emphasizes the critical need for a revolutionary, broad-spectrum, antiviral drug like NV-387 as another severe Ebolavirus outbreak has occurred in the Eastern part of DR Congo (DRC), with spillage across the border into Uganda."We believe NV-387 could be effective against the Bundibugyo strain of Ebola that is ravaging DRC," said Anil R. Diwan, PhD, adding, "All filoviruses including all Ebola strains utilize the sulfated proteoglycans for initial cell attachment; which is the feature that NV-387 presents to the viruses to destroy them."Viruses are unlikely to escape NV-387 because no matter how much the viruses change, they still depend upon their interaction with sulfated proteoglycans for initial attachment to cells, which NV-387 mimics.In contrast, antibodies and vaccines are highly specific, and are readily escaped by viruses. Further, antibodies require a cold chain and must be given as infusions in patients. The equipment and facilities for the cold chain and for infusion itself in a high isolation setting are generally not available in remote areas.NV-387 is an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[1]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.The WHO declared a Public Health Emergency of International Concern (PHEIC) for the Bundibugyo outbreak in Eastern DRC, with two cases in Uganda in travelers from Congo, on May 17, 2026[2]. The outbreak itself was declared on May 15, although the initial or "patient zero" case likely occurred in April, 2026. This delay was primarily because of the cases occurring in clusters in multiple remote locations that had limited reporting capabilities. The outbreak had already resulted in 88 deaths and at least 336 suspected cases[3]. WHO estimates there could be potentially a much larger outbreak with many unreported or undiagnosed cases.Some Americans currently in DRC have been affected. It is not clear if they have been traced as contacts, or have acquired infection awaiting diagnosis. The US CDC with other US departments is active in extracting these subjects exposed to ebolavirus and moving them into an isolated area for treatment, if necessary.[4]The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-20%, the potential threat of global pandemic from such an outbreak would increase substantially. Currently there is no apparent threat of a pandemic.With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus. Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic."Only safe and effective broad-spectrum antiviral drugs that can effectively combat most viral infections will enable the world to combat viruses and defend the global population in the war against known and unknown nanoscopic enemies that are viruses," commented Dr. Diwan, adding, "NV-387 is the only drug with such potential that is in clinical development today, to the best of our knowledge."ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com[1] Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.[2] https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern[3] https://www.forbes.com/sites/omerawan/2026/05/16/why-the-current-ebola-outbreak-in-congo-matters-to-the-entire-world/[4] https://www.statnews.com/2026/05/17/ebola-outbreak-congo-americans-exposure-suspected-cases/SOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: Ebola Global Health Emergency Needs a Broad-Spectrum Drug - NV-387 is a Strong Potential Candidate, Says NanoViricides
US Market News
3週前
NanoViricides Announces Pricing of ~$2 Million Registered Direct OfferingMay 15, 2026 8:35 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 15, 2026 / NanoViricides, Inc. (NYSE American:NNVC) ("NanoViricides" or the "Company"), a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape, today announced it has entered into a securities purchase agreement with a single fundamental institutional investor for the purchase and sale of 1,333,334 million common shares (or pre-funded warrants in lieu thereof), together with accompanying warrants to purchase 1,333,334 common shares for gross proceeds of approximately US$2 million in a registered direct offering (the "Offering"). The common shares are being sold in combination with an accompanying full warrant (with each whole warrant being exercisable into one common share of the Company). Each whole warrant has an exercise price of US$1.75 per share and will expire three years from the date of issuance.D. Boral Capital LLC is acting as the exclusive placement agent for the Offering.The closing of the Offering is expected to occur on or about May 18, 2026, subject to the satisfaction of customary closing conditions. The Company expects to receive aggregate gross proceeds of ~$2 million from the Offering, before deducting placement agent fees and other related expenses.The common shares (or pre-funded warrants in lieu thereof) are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333- 271706), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on May 22, 2023.A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC. Once filed, it will be available on the SEC's website at https://www.sec.gov. A copy of the prospectus supplement and accompanying base prospectus relating to the offering may be obtained, when available, from D. Boral Capital LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, or by telephone at (212) 404-7002, or by email at dbccapitalmarkets@dboralcapital.com.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About NanoViricidesNanoViricides, Inc., is a publicly traded company (NYSE American: NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape. Its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an "Orphan Drug Designation" (ODD) by the US FDA Office of Orphan Products Development (OOPD). This could provide 7 years market exclusivity, tax credits for clinical trial costs, and fee exemptions upon approval. NV-387 is a revolutionary antiviral that we believe will be the drug offered at "first visit" when the patient presents to a doctor with any respiratory viral illness. NV-387 was also found to be highly effective in lethal animal infection models of Influenza, RSV, Coronaviruses, Monkeypox, Smallpox, and Measles.Forward-Looking StatementsStatements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the use of words such as "may," "will," "plan," "should," "expect," "anticipate," "estimate," "continue," or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends, and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate and involve factors that may cause actual results to differ materially from those projected or suggested. These risks include, but are not limited to, the ability to complete the offering on the terms described or at all, the ability to satisfy customary closing conditions, market conditions, regulatory developments affecting the digital asset and stablecoin industries, and other risks described in the Company's filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading "Risk Factors" in the Company's Annual Reports on Form 20-F, as may be supplemented or amended by the Company's Reports of a Foreign Private Issuer on Form 6-K. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information, or otherwise.ContactsFor inquiries, contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:ir@nanoviricides.comSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: NanoViricides Announces Pricing of ~$2 Million Registered Direct Offering
US Market News
1月前
NanoViricides, Inc. Announces Participation in the D. Boral Capital Global ConferenceMay 6, 2026 3:37 PM
NewsfileShelton, Connecticut--(Newsfile Corp. - May 6, 2026) - NanoViricides, Inc. (NYSE American: NNVC), today announced its participation in the D. Boral Capital Global Conference, taking place May 7, 2026, at The Plaza Hotel in New York City.Anil R. Diwan, PhD, President & Exec. Chairman will be hosting one-on-one meetings on May 7th from 9:45 A.M. to 2:45 P.M. (ET).To register for one-on-one meetings with management at The Plaza Hotel in New York City, interested parties should contact the DBC Conference Team at dbcconferenceteam@dboralcapital.com.About NanoViricides, Inc.NanoViricides, Inc., is a publicly traded company (NYSE American: NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape. Its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an “Orphan Drug Designation” (ODD) by the US FDA Office of Orphan Products Development (OOPD). This could provide 7 years market exclusivity, tax credits for clinical trial costs, and fee exemptions upon approval. NV-387 is a revolutionary antiviral that we believe will be the drug offered at “ first visit” when the patient presents to a doctor with any respiratory viral illness. NV-387 was also found to be highly effective in lethal animal infection models of Influenza, RSV, Coronaviruses, Monkeypox, Smallpox, and Measles. About D. Boral CapitalD. Boral Capital LLC is a premier, relationship-driven global investment bank headquartered in New York. The firm is dedicated to delivering exceptional strategic advisory and tailored financial solutions to middle-market and emerging growth companies. With a proven track record, D. Boral Capital provides expert guidance to clients across diverse sectors worldwide, leveraging access to capital from key markets, including the United States, Asia, Europe, the Middle East, and Latin America. A recognized leader on Wall Street, D. Boral Capital has successfully aggregated approximately $35 billion in capital since its inception in 2020, executing ~400 transactions across a broad range of investment banking products. For further information:
Meeta R Vyas
CFO
?+1 (203) 937-6137?
info@nanoviricides.com
www.nanoviricides.comSource NanoViricides, Inc. Original: NanoViricides, Inc. Announces Participation in the D. Boral Capital Global Conference
US Market News
1月前
NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDAMay 4, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 4, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an "Orphan Drug Designation" (ODD) by the US FDA Office of Orphan Products Development (OOPD).The orphan drug designation will qualify NanoViricides for incentives including:Tax credits for qualified clinical trials;Exemption from certain user fees;Potential seven years of market exclusivity after approval;according to the US FDA[1]."The Orphan Drug Designation is an important milestone that will help us speed up the regulatory development of NV-387 for the Treatment of Measles," said Anil R. Diwan, PhD., adding, "NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved."NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.Measles cases have been rising globally. This year, a major epidemic has broken out in Bangladesh with over 227 children dead and over 35,000 cases, while Guatemala has an on-going Measles outbreak with over 5,300 cases and four deaths[2].Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks.Measles is endemic globally. Many countries that had achieved an elimination status for Measles have by now lost this status, due to severe outbreaks over the last three years[3].Measles cases have been rising in the USA. As of April 30, 2026, already 1,803 confirmed measles cases (excluding 11 in international travelers) were reported in the United States in 2026. in the year 2025, 2,251 confirmed cases with 3 deaths were reported, increasing from 285 in 2024 and 59 in 2023 (no deaths in these prior years). Vaccine breakthrough accounted for 6-7% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status. (CDC data[4]).Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases, which has qualified NV-387 for Measles Treatment as an Orphan Drug indication.NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application as well as the RPDD application. Dr. Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.In addition to the ODD, NanoViricides has also applied for a "Rare Pediatric Disease Drug" (RPDD) designation for NV-387 as a Treatment of Measles to the OOPD. The RPDD, if granted would additionally enable the Company eligible for a "Priority Review Voucher" (PRV). A PRV cuts the FDA review time for the corresponding NDA significantly. A PRV is tradable, and it has fetched $150~200 million dollars to the holder when traded. A PRV would provide a significant early revenue source for the Company, and would make a strong business case for prioritizing the development of NV-387 for Measles.There is no approved drug for the treatment of measles, although an effective vaccine exists and is generally given in a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age providing lifelong immunity. Measles is a highly contagious disease. A population vaccination rate of more than 95% is thought to be needed for blocking spread of measles if a case occurs. Vaccination rates have been dropping worldwide primarily due to vaccine hesitancy.Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.In absence of a treatment, quarantining of all contacts of a case for at least 14 days is the public health approach at present to minimize spread. Vaccination is urged but any vaccine requires 2-3 weeks from administration to become effective. Also, Measles vaccine requires 2 doses spread apart in time for full effectiveness.Quarantining causes significant disturbances in the society, in particular, causing significant loss of in-school days for children. A preventive NV-387 treatment of contacts could eliminate the need for quarantining, with a significant positive impact for children as well as economically.Thus, a drug for Measles is sorely needed for combating Measles worldwide.NV-387 is an extremely broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products[2] https://www.cidrap.umn.edu/measles/measles-case-counts-mount-utah-arizona-while-bangladesh-guatemala-battle-deadly-outbreaks (May 1, 2026, CIDRAP news).[3] https://www.cfr.org/articles/many-countries-eliminated-measles-why-is-it-coming-back-in-the-u-s-and-globally[4] https://www.cdc.gov/measles/data-research/index.htmlSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA
US Market News
2月前
Deadly Measles Cases Accentuate the Need for a Treatment - NV-387 is Here to Help Patients and Control Spread, Says NanoViricidesApril 21, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / April 21, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, comments that its drug candidate NV-387 is the weapon necessary for combatting growing cases of deadly measles worldwide.Bangladesh recently reported 18,219 suspected measles cases, including 2,897 confirmed cases, and 164 suspected case deaths, with transmission in 58 of 64 districts, in the single month of March 15 to April 14, 2026[1]. Over 80% of the cases are in children under the age of 5 years, and most of the deaths are in unvaccinated cases. The nation has rolled out a vaccination campaign which is expected to reach 1.2 million children in 18 of the 64 districts in the first phase."This response clearly leaves out treating patients which is the immediate need," said Anil R. Diwan, PhD, adding, "Our drug NV-387 is currently the only medical countermeasure that can help these patients and save lives."A treatment such as NV-387 would help curtail the transmission chain as well, which would help stall the epidemic sooner. This is because a patient recovering in a shorter timeframe due to receiving treatment compared to without treatment means less days of further transmission from the patient.Additionally, contacts including health care workers can be treated with the same drug in smaller doses to prevent infection and transmission immediately.In contrast to the immediate effect of drug treatment, a vaccinated individual becomes protected only after 2-3 weeks post vaccination; so they continue to remain at risk while immersed in the epidemic. Also worth noting is the fact that measles vaccination requires two doses separated over several weeks in order to reach maximum effectiveness.NV-387, we believe, is the only drug candidate that has been shown to be effective and safe in specially humanized animal model studies of lethal Measles virus infection (humanized h-CD150+ knock-in, IfnAR-/- genotyped mice), as reported previously by NanoViricides. NV-387 has completed a Phase I clinical trial with no reported adverse events, indicating excellent safety and tolerability in humans.As of April 16, there were 1,738 confirmed measles cases reported by 33 jurisdictions in the USA according to CDC[2]. Since then, at least two additional states have reported cases.Measles 2-dose vaccine is considered to be highly effective, with only a 10-11% breakthrough rate (i.e. infection in vaccinees). This is in spite of the fact that the vaccine was developed 60 years ago, by attenuating genotype A measles virus, whereas current circulating viruses are genotype D8 and B3, among others. Although the virus has continued to mutate, the receptor binding sites on the viral glycoprotein H are not hidden from the immune system, and also these sites are functionally conserved despite mutations. This is why infection with any measles virus (vaccine strain or circulating "wild-type") protects against substantially all genotypes.Nevertheless, infants under the vaccination age (especially after 3 months when the maternal antibodies in the infant wane), immune-compromised persons including HIV, persons with morbidities such as diabetes, auto-immune diseases, etc. cannot generate sufficiently high levels of protection from vaccines. These groups, as well as health care workers (the latter due to high exposure risk) remain susceptible despite vaccination. As such, even if these groups catch asymptomatic or mild infection, they would potentially transmit the virus to others.This is why having a treatment as a complement to the vaccine is essential for containment towards elimination and eventually potentially eradication of measles virus. At present, NV-387 is the only drug candidate that we know of that fulfills this unmet medical need.Measles is considered a rare orphan disease in the USA. It is also a rare pediatric disease. As such, NV-387 for the treatment of Measles would qualify for an Orphan Drug Designation (ODD) together with a Rare Pediatric Disease Drug (RPDD) designation. These designations provide sponsors with incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval[3]. Additionally, RPDD would qualify NV-387 for issuance of a Priority Review Voucher (PRV) upon drug approval. NanoViricides has applied for NV-387 as a treatment for measles for ODD as well as RPDD to the US FDA.A PRV is a tradable instrument and can fetch cash value of $150 million to $200 million. A PRV, if granted, would thus significantly improve the business case for the regulatory development of NV-387 as a measles treatment.ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.who.int/southeastasia/news/detail/15-04-2026-response-measlesBN[2] https://www.cdc.gov/measles/data-research/index.html[3] https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-productsSOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: Deadly Measles Cases Accentuate the Need for a Treatment - NV-387 is Here to Help Patients and Control Spread, Says NanoViricides
US Market News
2月前
Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricidesApril 7, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / April 7, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for "Rare Pediatric Disease Drug" Designation (RPDD) for NV-387 as a Treatment for Measles with the US FDA Office of Orphan Products Development (OOPD). This RPDD application is expected to be joined together with the Orphan Drug Designation application for NV-387 as a Treatment for Measles that the Company has filed in February, 2026.NanoViricides will be eligible for a Priority Review Voucher (PRV) upon approval of the drug if NV-387 is designated as a Rare Pediatric Disease Drug. A PRV carries immediate economic value. It is a tradable instrument, and recently has generally fetched around $160 million upon sale of the PRV to another company [1]. A PRV carries the benefit of accelerated approval of the drug for which it is used by the purchaser, which brings this value to the PRV."NV-387 as an effective drug is expected to be an important tool to fight Measles resurgence in the USA and worldwide, when approved," said Anil R. Diwan, PhD, adding, "Treating a Measles patient with NV-387 would help with rapid recovery and eliminate the high morbidity and the rare post-Measles ‘Immune Amnesia' effects." "A Rare Pediatric Disease Drug Designation for NV-387 would help us tremendously in the mission of regulatory development and approval of NV-387 to treat Measles, by substantially boosting the potential economic benefits and the business case for this indication," said Meeta R. Vyas, CFO of the Company.There is no drug for the treatment of Measles at present.The Rare Pediatric Disease Priority Review Voucher program was re-authorized by the US Congress and signed into Law by President Trump on February 3, 2026, as part of the Consolidated Appropriations Act of 2026 [2].Measles cases have been rising in the USA, with 1,661 laboratory confirmed cases already reported, with occurrences across 33 states, with 17 new outbreaks, as of April 2, 2026, according to the CDC [3]. An additional 10 cases were reported to have occurred in international travelers visiting the USA. A total of 2,286 confirmed cases in 48 outbreaks were reported in 2025. The rate of hospitalization in 2026 has decreased to about 5% from the 11% rate in 2025. This decrease is presumably due to a better understanding of case handling guidelines, and the strong efforts of the CDC including updated information and toolkits for Public Health and Healthcare professionals [4].Measles is a rare disease in the USA, with annual incidence rates well below 200,000 cases. About 70% of the cases have been in pediatric subjects (0-18 years of age), which qualifies NV-387 for Measles Treatment as a Rare Pediatric Disease Drug.At least 8% of cases in 2026 to date, and at least 7% of cases in 2025 occurred in vaccinated individuals. The CDC reports the vaccine breakthrough rate at about 10%.Infants below 9 months of age are not eligible for routine vaccination. Recently, at least 100 child deaths due to Measles were reported in Bangladesh during 2026, with a large portion of them in infants, leading to a vaccination campaign relaxing this lower age limit [5].NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the RPDD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.There is no approved drug for the treatment of measles, although an effective vaccine exists and is generally given in a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age providing lifelong immunity. Measles is a highly contagious disease. A population vaccination rate of more than 95% is thought to be needed for blocking spread of measles if a case occurs. Vaccination rates have been dropping worldwide primarily due to vaccine hesitancy.Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.In absence of a treatment, quarantining of all contacts of a case for at least 14 days is the public health approach at present to minimize spread. Vaccination is urged for contacts but any vaccine requires 2-3 weeks from administration to become effective. Also, Measles vaccine requires 2 doses spread apart in time for full effectiveness.Quarantining causes significant disturbances in the society, in particular, causing significant loss of in-school days for children. A preventive NV-387 treatment of contacts would eliminate the need for quarantining, with a significant positive impact for children as well as economically.NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks. Measles is endemic in the developing and less developed nations.Thus, a drug for Measles is sorely needed for combating Measles worldwide.NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.Over 90% of human pathogenic viruses are expected to be susceptible to NV-387, based on its design as a sulfated proteoglycan mimetic.ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour ® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.fiercepharma.com/pharma/bavarian-nordic-sells-priority-review-voucher-chikungunya-vaccine-approval-160m .[2] https://www.fiercepharma.com/pharma/fdas-rare-pediatric-disease-voucher-program-revived-2026-government-funding-bill .[3] https://www.cdc.gov/measles/data-research/index.html[4] https://www.cdc.gov/measles/php/toolkit/index.html[5] https://www.foxnews.com/health/least-46-children-dead-amid-measles-outbreak-virus-spreads-globally ; https://www.bbc.com/news/articles/cevkz2z7dm8oSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricides
US Market News
2月前
Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricidesApril 1, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / April 1, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo (DRC).Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel are expected to visit the Site for final preparations and for staff training in the first week of April, 2026. Enrollment and dosing of patients is expected to begin after the staff training is completed.The Company previously reported that it has received approval to start said Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC).The Phase II clinical trial will evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection.MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I."This is an important milestone in regulatory development of NV-387," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.There is no drug available for the treatment of hMPXV infection that causes the MPox disease.NV-387 would be the "go to" pandemic response candidate if it is successful in the Phase II MPox clinical trial. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387.MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.MPox Clade I cases in the USA have been slowly increasing. As of March 23, 2026, there have been 15 cases of MPox Clade I in the USA since November, '25, with 4 of them in March, '26, according to CDC[1].Community spread of the MPXV Clade I is likely already occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC[2].Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study[3]. The effectiveness of this vaccine is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II[4].The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic.A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024. Another drug, brincidofovir (TEMBEXA®, EBS) entered into a clinical trial called "MOSA" with fanfare in January, 2025, with early topline results expected by the end of that quarter. The status of this clinical trial is not publicly known as of now. Previously, three MPox cases treated with TEMBEXA developed liver dysfunction. TEMBEXA carries a black-box warning, due to severe liver toxicity, entero-gastric toxicity, and requires clinical monitoring, making it unsuitable as a drug for pandemic response.Thus both of the Smallpox drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads, representing an opportunity for NV-387."NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria."NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37. Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu ® ), baloxavir (Xofluza ® ) for Influenza are readily escaped by viruses simply by introduction of small changes that viruses undergo when they are faced with these challenges in the field.In contrast, escape of virus from NV-387 is highly unlikely because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.NV-387 is a host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, and their limitations have become clearly evident during the COVID-19 pandemic.About NanoViricidesNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour ® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.Where stated with an ®, the name is a registered trademark, which belongs to the owner of the trademark name.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.cdc.gov/monkeypox/situation-summary/index.html[2] https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case[3] https://www.cidrap.umn.edu/mpox/amid-new-mpox-outbreak-study-suggests-waning-protection-jynneos-vaccine[4] From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43.SOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricides
drkazmd65
3月前
NanoViricides Presenting at NIBA's 152nd Investment Conference in Fort Lauderdale, FL March 12, 2026 - Announces Manufacture of Phase II Clinical Product NV-387 Oral Gummies is Complete.
https://finviz.com/news/336418/nanoviricides-presenting-at-nibas-152nd-investment-conference-in-fort-lauderdale-fl-march-12-2026-announces-manufacture-of-phase-ii-clinical-product-nv-387-oral-gummies-is-complete
By ACCESSWIRE | March 11, 2026, 8:30 AM
SHELTON, CT / ACCESS Newswire / March 11, 2026 / NanoViricides, Inc. (AMEX:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, is pleased to announce that it will be presenting at NIBA's 152nd Investment Conference in Fort Lauderdale, Florida.
NanoViricides announces herewith that the manufacture of the drug product for this clinical trial, "NV-387 Oral Gummies" is now complete, in anticipation of starting dosing in patients as soon as site readiness is established.
Anil R. Diwan, PhD, President and Executive Chairman of the Company will deliver a company presentation on Thursday, March 12th at 11:50 am ET, and will be available for one-on-one investor meetings throughout the event.
NV-387, NanoViricides' lead clinical stage drug, is an extremely broad-spectrum antiviral drug that is poised to revolutionize the treatment of respiratory antiviral infections just as antibiotics have revolutionized the treatment of bacterial infections. NV-387 has multiple indications in development, including, RSV, Influenza, Coronaviruses (including COVID), Monkeypox, Smallpox, Measles, as well as Viral Acute Respiratory Infections (V-ARI), and Severe ARIs (V-SARI).
NV-387, as an oral drug, has successfully completed a Phase I clinical trial and healthy human subjects with no dropouts and no reported adverse events, indicating excellent safety and tolerability.
NV-387 has been approved to enter a Phase II clinical trial for the treatment of Monkeypox (MPox) by the regulatory agency ACOREP of the Democratic Republic of Congo (DRC).
NanoViricides is developing first-in-class antiviral drugs that act by a novel mechanism of action, enabling unparalleled broad-spectrum antiviral activity as well as safety. The Nanoviricides technology defines a novel antiviral mode of action that we call "Re-Infection Inhibition". A "nanoviricide™" is designed to look like a cell to the virus, presenting a high concentration of virus-binding ligands on its surface. Upon binding of the virus, the nanoviricide is further designed to change shape and engulf the virus particle, rendering it incapable of infecting cells.
Viruses are unlikely to escape the nanoviricide platform drugs, because the nanoviricide platform drugs mimic the essential feature on the hist cell that the viruses require, and continue to use, even as they go through a multitude of changes in their genomes and their protein makeup, via mutations, recombinations and in some cases, re-assortments.
About National Investment Banking Association (NIBA)
The National Investment Banking Association (NIBA) is a non-profit organization that has been serving the micro-cap and small-cap investment community for over 40 years. NIBA's 152nd Investment Conference website is available here:
https://nibas-152nd-investment-conference.events.accessnewswire.com/.
ABOUT NANOVIRICIDES
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections. NV-387 is a unique broad-spectrum antiviral that is also effective in animal models for Monkeypox (MPox), Smallpox, as well as Measles.
Our other advanced drug candidate is NV-HHV-1 for the treatment of all Herpesvirus infections including HSV-1 "cold sores", HSV-2 "genital ulcers, VZV Shingles and Chickenpox. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants.
NV-387 has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
Forward-looking statements: This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Media Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides
US Market News
4月前
MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricidesFebruary 12, 2026 8:30 AM
ACCESS NewswireSHELTON, CONNECTICUT / ACCESS Newswire / February 12, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox" with the US FDA Office of Orphan Products Development (OOPD).If approved, orphan drug designation will qualify NanoViricides for incentives including:Tax credits for qualified clinical trials;Exemption from certain user fees;Potential seven years of market exclusivity after approval;according to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products)."NV-387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat."WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus.MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern.There is no approved drug for the treatment of MPox. Tecovirimat (TPOXX®, SIGA) and brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule". Tecovirimat has failed to show any clinical effectiveness, and did not show any viral load reduction benefit either, over standard of care in a clinical trial for treatment of MPXV infections1. Mutants resistant to tecovirimat were found to be generated in some cases. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study"2. In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial3. The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results.The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles4.MPXV has continued to mutate in the African region. Mutants resistant to the JYNNEOS® Smallpox vaccine that was fielded to control the spread of MPXV Clade Ia/Ib have been found. The antibody response to MPXV from the JYNNEOS vaccine was found to be poor and short-lived5.The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX.NV-387 has shown strong effectiveness in a mouse model of dermal lethal infection of ectromelia, an orthopoxvirus closely related to viruses that cause smallpox and mpox. NV-387 has successfully completed a Phase I human clinical trial demonstrating safety and tolerability in healthy adults with no reported adverse events. Therefore the Company believes that NV-387 is a viable clinical candidate for the treatment of MPox.In the USA, MPOX incidence rate was approximately 2,042 cases in 2025, well below 200,000 cases6. Thus NV-387 for the Treatment of MPox qualifies for Orphan Drug Designation.NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.Viral resistance to NV-387 is unlikely because this drug mimics specific cell-side features that these viruses continue to employ to effectively infect human host cells, despite how much they may change in the field. In contrast, viruses mutations readily result in making traditional vaccines, antibodies, and small chemical drugs ineffective.Further, NV-387 is a complete chemical nanomachine that completes the task of binding to, engulfing, and destroying virus particles without any dependence on the human immune system.These factors make NV-387 unique in the field of antiviral drugs and vaccines.ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.com1The PALM007 Writing Group, "Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo", N Engl J Med 2025;392:1484-96. DOI: 10.1056/NEJMoa2412439.2Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, https://doi.org/10.1016/ S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network .3https://mpx-response.eu/treating-mpox-in-africa-mosa-begins-patient-enrollment-in-drc/.4Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir.5Phipps, K. et al. "Short-Lived Neutralizing Antibody Responses to Monkeypox Virus in Smallpox Vaccine-Naive Persons after JYNNEOS Vaccination." Wadsworth Center, New York State Department of Health and Univ. of Albany, NY. Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 31, No. 2, February 2025. DOI: https://doi.org/10.3201/eid3102.241300 .6https://www.cdc.gov/monkeypox/data-research/cases/index.html.SOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides
US Market News
4月前
Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricidesFebruary 10, 2026 8:30 AM
ACCESS NewswireSHELTON, CONNECTICUT / ACCESS Newswire / February 10, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for "Orphan Drug Designation" (ODD) for NV-387 as a Treatment for Measles with the US FDA Office of Orphan Products Development (OOPD).If approved, orphan drug designation will qualify NanoViricides for incentives including:Tax credits for qualified clinical trials;Exemption from certain user fees;Potential seven years of market exclusivity after approval;According to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products)."NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved," said Anil R. Diwan, PhD, adding, "Treating a patient and providing the drug prophylactically to contacts would eliminate the need for quarantine and loss of valuable school time. An Orphan Drug Designation would help us tremendously in the mission of regulatory development and approval of NV-387 to treat Measles."Measles cases have been rising in the USA reaching 2,251 confirmed cases with 3 deaths in 2025, from 285 in 2024 and 59 in 2023 (no deaths in these prior years). As of February 5, 2026, already 727 confirmed measles cases were reported in the United States in 2026. Vaccine breakthrough accounted for 6-7% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status (https://www.cdc.gov/measles/data-research/index.html). Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases, which qualifies NV-387 for Measles Treatment as an Orphan Drug indication.NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.There is no approved drug for the treatment of measles, although an effective vaccine exists and is generally given in a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age providing lifelong immunity. Measles is a highly contagious disease. A population vaccination rate of more than 95% is thought to be needed for blocking spread of measles if a case occurs. Vaccination rates have been dropping worldwide primarily due to vaccine hesitancy.Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.In absence of a treatment, quarantining of all contacts of a case for at least 14 days is the public health approach at present to minimize spread. Vaccination is urged but any vaccine requires 2-3 weeks from administration to become effective. Also, Measles vaccine requires 2 doses spread apart in time for full effectiveness.Quarantining causes significant disturbances in the society, in particular, causing significant loss of in-school days for children. A preventive NV-387 treatment of contacts would eliminate the need for quarantining, with a significant positive impact for children as well as economically.NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks. Measles is endemic in the developing and less developed nations.Thus, a drug for Measles is sorely needed for combating Measles worldwide.NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.ABOUT NANOVIRICIDESNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour ® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.comSOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides