Redhill Biopharma Ltd (RDHL) 銘柄情報

Still a turd. Nothing moves this stock up ever.

Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development

Heightened geopolitical tensions and Homeland Security concerns call for the development of potential therapies that can be quickly and easily mobilized in the event of a mass casualty nuclear or radiological incident

There are currently no known approved therapies for gastrointestinal acute radiation syndrome (GI-ARS)

Positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirm opaganib's protective activity

Discussions now ongoing with the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID), which leads the RNCP, regarding plans for the next phase of development along the U.S. Food and Drug Administration's (FDA) Animal Rule pathway to approval

TEL AVIV, Israel and RALEIGH, N.C., Dec. 10, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive results from new in vivo studies of opaganib[1] as a treatment for gastrointestinal acute radiation syndrome (GI-ARS), undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib, that further confirm opaganib's protective activity in models of GI-ARS.

The Company, together with the National Institutes of Allergy and Infectious Diseases (NIAID), which leads the U.S. government's RNCP, now plan to discuss the next phase of opaganib's U.S. government-funded development, along the U.S. Food and Drug Administration's (FDA) Animal Rule pathway, as a medical countermeasure against GI-ARS. The FDA's Animal Rule pathway to approval allows for pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible.

"There are currently no known approved therapies for GI-ARS. Growing geopolitical tensions and Homeland Security concerns call for development of new potential therapies that can be quickly and easily deployed in the event of a mass casualty nuclear or radiological incident," said Gilead Raday, RedHill's Chief Operating Officer and Head of Research and Development. "Opaganib, as an oral, small molecule pill that is highly stable with a more than five-year shelf-life, is easy to administer and distribute, supporting, if approved, potential central stockpiling by governments for use when needed."

With multiple U.S. government collaborations for chemical and medical countermeasures and pandemic preparedness, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule, clinical-stage drug with demonstrated safety & efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases and chemical and nuclear/radioprotection indications.

About Acute Radiation Syndrome (ARS)

ARS, sometimes known as radiation toxicity or radiation sickness, is generally rare; however, public health emergencies, such as a nuclear power plant accident or detonation of a nuclear device, could affect large numbers of people. ARS is an acute illness caused by irradiation of the body by a high dose of penetrating radiation in a short period of time. Much of the damage caused by ARS is caused by inflammation secondary to the direct effects of ionizing radiation itself.

Current treatments for ARS are supportive care, including blood transfusions, antibiotics, etc., as well as the availability of four approved products to mitigate hematologic-ARS (three growth factors to address neutropenia and one to mitigate thrombocytopenia). However, other radiation-induced clinical manifestations that have been observed in natural history studies, and remain unaddressed with the current treatments, include GI-ARS, cutaneous injury, and late effects in the lung, heart, and kidneys. Opaganib, an SPHK2 inhibitor, may offer a new therapeutic approach to mitigate GI-ARS. It has also been reported in the literature that inhibition of SPHK2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.

RedHill Biopharma Awarded Judgment of Approximately $8 Million Plus Costs by New York Supreme Court

https://finance.yahoo.com/news/redhill-biopharma-awarded-judgment-approximately-120000878.html

RedHill has been awarded a judgment of approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd

The Court dismissed the entirety of Kukbo's counterclaims, ruling in favor of RedHill's demonstrated good faith commitment to the spirit and the letter of the agreements

TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been awarded approximately $8 million (consisting of $6.5 million plus interest amounting to approximately $1.5 million), plus costs in a summary judgment by the Supreme Court of the State of New York, New York County (the "Court"), in its legal proceedings (Index number: 653200/2022) against Kukbo Co. Ltd. ("Kukbo"), domiciled in South Korea.


The case refers to Kukbo's failure to make agreed payments to RedHill, pursuant to a Subscription Agreement (the "SA"), dated October 25, 2021, and a subsequent Exclusive License Agreement (the "ELA" and together with the SA, the "Agreements"), dated March 14, 2022, entered into by the two companies.

Dror Ben-Asher, RedHill's CEO: "RedHill thanks the Court for this crystal-clear judgment, affirming the Company's just position from the beginning of the relationship, and in making correct provision for full reparation for the contractual breaches. The Company is also grateful to Haynes and Boone, LLP for their expert counsel and legal representation in this case."

Upon entry, Kukbo has a right to seek an appeal of the judgment, which may or may not be granted. RedHill intends to pursue its attorneys' fees and collection of the judgment.

RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND

RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day"
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Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA
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The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-CBRND's mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations
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With multiple U.S. government collaborations for chemical and MCMs and pandemic preparedness, opaganib is a novel, host-directed, potentially broad-acting, orally administered small molecule, clinical-stage drug with demonstrated safety and efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection indications

TEL-AVIV, Israel and RALEIGH, N.C., Oct. 28, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been selected to further elaborate on opaganib's[1] potential in a presentation to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day". The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA.

The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-CBRND mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations. Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and treatment of exposure to viruses, bacteria and toxins.

"Opaganib is already the subject of multiple ongoing collaborations with several U.S. government agencies. However, selection for presentation at this important governmental investment event provides a significant opportunity to highlight the growing body of evidence in support of opaganib's potential as an oral, host-directed, broad-acting viral, chemical and nuclear countermeasure," said Guy Goldberg, RedHill's Chief Business Officer.

RedHill Announces Collaboration with a Leading U.S. Academic Medical Center to Develop Opaganib as a Countermeasure Against Phosgene Inhalation Injury

https://finance.yahoo.com/news/redhill-announces-collaboration-leading-u-110000807.html

The collaboration outlines plans for multiple in vivo studies, designed to test opaganib as a potential medical countermeasure to treat phosgene inhalation injury. The collaboration aims to determine whether opaganib can advance into further definitive U.S. government-sponsored development under the FDA's Animal Rule pathway to approval

Used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is today widely used in industrial processes for the manufacture of plastics and pesticides. The U.S. Environmental Protection Agency (EPA) identified 123 sites in the United States that could potentially expose millions of people to phosgene due to plant malfunction or bioterrorism[1]

Phosgene inhalation can be extremely dangerous, causing significant, even fatal, respiratory injury. No known approved antidote or reversal agent currently exists, and, if approved, opaganib may provide potential for stockpiling for emergency use in the event of a major public safety incident

With multiple U.S. government collaborations for chemical and medical countermeasures and pandemic preparedness, RedHill's opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule, clinical-stage drug with demonstrated safety & efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases and chemical and nuclear/radioprotection indications

TEL AVIV, Israel and RALEIGH, N.C., Oct. 22, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a collaborative research agreement with Duke University School of Medicine outlining plans for multiple in vivo studies. The program is designed to test opaganib[2] as a potential medical countermeasure to treat phosgene inhalation injury, aimed at providing results sufficient to advance opaganib into further definitive U.S. government-sponsored development under the U.S. Food and Drug Administration's (FDA) Animal Rule pathway to approval. The FDA Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible. Under this research agreement, RedHill will provide required drug quantities for animal studies, analytical support to quantify drug concentrations in plasma samples, and share dosing regimen with the Achanta Lab at Duke University.

"Opaganib is currently being tested, by various governmental research bodies, in multiple areas that urgently require new chemical and medical countermeasure therapeutic options," said Dr. Satya Achanta, D.V.M., Ph.D., Assistant Professor in the Department of Anesthesiology at Duke University School of Medicine. "Our research will help determine whether there is a potential protective role of opaganib in limiting damage caused by phosgene inhalation."

"Notably used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is today widely used in industrial processes for the manufacture of plastics and pesticides. The U.S. Environmental Protection Agency (EPA) identified 123 sites in the United States that could expose millions of people to phosgene potentially due to plant malfunction or bioterrorism," said Gilead Raday, RedHill's Chief Operating Officer and Head of Research and Development. "This exciting collaboration with Duke University School of Medicine could pave the way to a potential therapy for the acute respiratory distress syndrome (ARDS) phosgene inhalation can cause, which can be extremely dangerous, causing significant, even fatal, injury. No known approved antidote or reversal agent currently exists, and, if approved, opaganib may provide potential for stockpiling for emergency use in the event of a major public safety incident."

What is Phosgene inhalation injury

Phosgene inhalation injury occurs when someone breathes in phosgene gas (COCl2), a toxic chemical primarily used in industrial processes. Phosgene has a distinct odor, similar to freshly mown grass or hay. However, only 10% of the population may detect this odor at lower concentrations. The combination of its unassuming odor and poor human detection makes phosgene particularly dangerous. At higher concentrations, it is extremely dangerous, even fatal, and is a cause of acute respiratory distress syndrome (ARDS). It is believed that no antidotes or reversal agents exist at this time. Phosgene was notably used as a chemical weapon during World War I.

Today, phosgene use in industry is ubiquitous - being used in the production of polymers, plastics and pesticides. Global estimates indicate that more than 12 million metric tons are produced annually[3]. Despite its widespread use, some regions poorly regulate its production, and concern exists for its potential as a weapon of bioterrorism. Given its severe toxicity and high mortality, research is primarily limited to an Animal Rule pathway to approval, which allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible.

The EPA identified 123 sites in the United States that could expose millions of people to phosgene if the plant malfunctions or becomes a target of bioterrorism.

RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment

https://finance.yahoo.com/news/redhill-biopharma-secures-u-government-110000019.html

The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat Ebola virus disease (EBOV)
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The funding advances opaganib's positive development progress to date on the expected FDA Animal Rule pathway toward potential approval as an MCM for EBOV
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Recent U.S. Army-funded studies showed that opaganib delivered a statistically significant increase in survival in an in vivo EBOV model. The BARDA research and development contract provides initial funding for the collaboration, in pursuit of advancing opaganib to mitigate infection and contain EBOV outbreaks
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This year marks the 10th anniversary of the West Africa Ebola epidemic in which 11,000 people died, and there is still an urgent need for effective and useable therapies, with EBOV proving fatal in around half of all cases according to the World Health Organization (WHO)1
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Opaganib, a novel potentially broad-acting drug, has shown mutation-resistant antiviral and anti-inflammatory activity, likely to directly impact vascular health - one of the main targets for EBOV dysfunction. It is believed to be the first host-directed molecule to show activity in EBOV in vivo and represents an alternative host-directed therapeutic strategy for biodefense and global health preparedness. Additional U.S. government collaborations with opaganib are ongoing
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Significant geopolitical and logistical challenges exist in managing outbreaks of disease and there is an urgent need for safe and effective, oral, small molecule therapeutics that can be stored and easily distributed and administered in an outbreak

TEL-AVIV, Israel and RALEIGH, N.C., Oct. 14, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services (HHS)' Administration for Strategic Preparedness and Response (ASPR), has selected opaganib2 for development to treat exposure to Ebola virus disease (EBOV).

Under this cost-sharing contract, BARDA will provide partial funding for the company to further advance opaganib to mitigate infection and contain EBOV outbreaks. To date, opaganib has made positive development progress on the expected Animal Rule pathway towards potential approval as a treatment for EBOV. The Animal Rule allows for the use of pivotal animal model efficacy studies to support U.S. Food and Drug Administration (FDA) approval of new drugs when human clinical trials are not ethical or feasible.

"EBOV is deadly, killing, on average, half of all those who contract it. This year marks 10 years since the West Africa Ebola epidemic in which 11,000 people died, and yet there are still no host-directed, small molecule therapies approved to provide effective and useable treatment strategies," said Guy Goldberg, RedHill's Chief Business Officer. "Currently only Inmazeb™, a combination of three monoclonal antibodies, and Ebanga™, a single monoclonal antibody, are FDA-approved to treat EBOV, as such there is an urgent medical need for additional effective and easy to distribute and administer EBOV therapies. There are also enormous geopolitical and logistical challenges to overcome in managing outbreaks such as EBOV, and others like Mpox, and so new host-directed, small molecule therapeutic options for biodefense and global health preparedness could prove to be major life-saving advances – this is especially true if they are capable of viral mutation-resistance, have extended shelf-lives for long-term storage, are relatively straightforward to transport to hard-to-reach territories, and are easy to administer without the need for cold-storage or injections."

Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo EBOV study, making it the first host-directed molecule to show activity in EBOV. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro EBOV study.

Opaganib is currently also in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, acute respiratory distress syndrome (ARDS) and radiological and chemical protection or mitigation.

This project is supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50124C00059.

None of this means anything to the stock price. Unless they get an approved drug through the government studies this stock will never do I thing that much I have come to realize.

RedHill and Medi-Cal Deal Maintains Talicia® Reimbursement Without Prior Authorization for 15 Million Californians

https://finance.yahoo.com/news/redhill-medi-cal-deal-maintains-110000468.html

Medi-Cal, California's Medicaid healthcare program, and RedHill have renewed their contract to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization and a $0 copay – a major benefit for approximately fifteen million Californian Medi-Cal patients
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The renewed terms reflect both parties' ongoing commitment to improving patient access and outcomes, reinforcing Talicia's role as an essential treatment option, and follow the new American College of Gastroenterology (ACG) Clinical Guideline1 for H. pylori infection, listing Talicia as an empirically prescribed first-line option
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Talicia's convenient all-in-one three-times daily (TID) formulation offers a simplified patient experience, supporting high rates of H. pylori eradication without the requirement of prior resistance testing, and continues to be the branded H. pylori therapy most prescribed by U.S. gastroenterologists2
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H. pylori infection affects approximately 35% of the U.S. adult population3 and is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer4 and a major risk factor for peptic ulcer disease5

RALEIGH, N.C. and TEL AVIV, Israel, Oct. 1, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the renewal of its contract with Medi-Cal, California's Medicaid healthcare program, to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization and a $0 copay, effective October 1, 2024.

"This renewed agreement with Medi-Cal is great news for the approximately 15 million Californian patients who rely on Medi-Cal and represents a clear vote of confidence in the safety and efficacy of Talicia, which has been listed by Medi-Cal since 2021," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "The continuing access to Talicia further reflects the strength of our collaboration and aligned commitment to improving patient care. This agreement comes in the wake of the publication of the new American College of Gastroenterology (ACG) Clinical Guideline for H. pylori infection, listing Talicia as an empirically prescribed first-line option – a clear scientific validation of Talicia's effective, simple and convenient all-in-one three-times daily (TID) therapeutic approach, supporting high rates of H. pylori eradication without the need for prior resistance testing."

RedHill Announces New U.S. Coronavirus Patent for Opaganib, Valid Through 2041

https://finance.yahoo.com/news/redhill-announces-u-coronavirus-patent-110000095.html

New U.S. patent issued covering the identification of a novel biomarker of coronavirus pneumonia (=60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib efficacy in treating COVID-19, valid through 2041

Published post-hoc data from opaganib's Phase2/3 study showed that patients with =60% FiO2 levels had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134), including: increased number of patients no longer requiring supplemental oxygen by day 14 of opaganib treatment (76.9% vs. 63.4%; p-value =0.033), a 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; p-value=0.012) and a clinically meaningful 62% reduction in mortality (5.98% vs. 16.7%; p-value=0.019) by day 42[1]

With multiple U.S. government collaborations for medical countermeasure and pandemic preparedness, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases and nuclear/radioprotection indications

TEL-AVIV, Israel and RALEIGH, N.C., Sept. 30, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new U.S. patent for identification of a novel biomarker of coronavirus pneumonia (=60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib[2] efficacy in treating COVID-19, valid through 2041 (U.S. Patent and Trademark Office Number: 12,115,150, date of grant to be: October 15, 2024).

Guy Goldberg, RedHill's Chief Business Officer, said: "This exciting new patent is based on compelling published post-hoc data from opaganib's Phase 2/3 study, showing that patients with =60% FiO2 levels had better outcomes after 14 days' opaganib treatment. These outcomes included an increase in patients no longer requiring supplemental oxygen by day 14 of opaganib treatment, a reduction in patients requiring intubation/mechanical ventilation and a clinically meaningful 62% reduction in mortality. This is a very interesting addition to the already strong patent portfolio protecting opaganib."

About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.

Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services' National Institutes of Health and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA).

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms.

Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[3], and Aemcolo®, for the treatment of travelers' diarrhea in adults[4]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.

More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.

RedHill Biopharma Ltd. (NASDAQ:RDHL) Short Interest Update

https://www.marketbeat.com/instant-alerts/nasdaq-rdhl-options-data-report-2024-09-26/

12.49 +2.19 (+21.32%)
As of 2:26 PM EDT. Market Open.
Going Places!

Hopefully Talicia sales will increase as a
result of todays PR.

RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines

https://finance.yahoo.com/news/redhills-talicia-listed-first-line-110000435.html

First new American College of Gastroenterology (ACG) Clinical Guideline[1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option

Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of eradication without needing prior resistance testing

Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for H. pylori infection, which affects approximately 35% of the U.S. adult population[3]

Worldwide, around 66% of the population has H. pylori infection[4], which is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer[5] and a major risk factor for peptic ulcer disease[6]

RALEIGH, N.C. and TEL-AVIV, Israel, Sept. 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the placement of low-dose rifabutin-triple therapy, Talicia, as an empirically-prescribed first-line option for the treatment of Helicobacter pylori (H. pylori) infection in the newly published American College of Gastroenterology (ACG) Clinical Guideline: Treatment of H. pylori Infection, previously updated in 2017.

"The ACG Clinical Guideline is clear that clarithromycin-based triple therapy is no longer a reliable first-line option for the treatment of H. pylori infection, unless prior resistance testing has shown clarithromycin susceptibility. Resistance rates to both of the antibiotics contained in Talicia, amoxicillin and rifabutin, are minimal - <3.0% and <1.0%, respectively[7] - supporting Talicia as a rational empirically-prescribed first-line option," Dr. Colin W. Howden, MD, Professor Emeritus, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center. "Talicia's all-in-one formulation and flexible dosing schedule – three times daily (TID), at least four hours apart with food, for 14 days – offers a simplified patient experience, supporting high rates of eradication without the requirement of prior resistance testing."

It has been almost eight years since the ACG Clinical Guideline's last update, which was prior to the launch of Talicia. "The newly updated ACG Clinical Guideline confirms the use of Talicia as a first-line option," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "Healthcare providers can be confident in their choice of Talicia without the requirement of prior resistance testing, and we trust that this newly updated ACG Clinical Guideline will continue to change the status quo of H. pylori treatment to further improve patient outcomes."

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

https://finance.yahoo.com/news/redhill-biopharma-regains-compliance-nasdaq-110000778.html

TEL AVIV, Israel and RALEIGH, N.C., Sept. 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from the Listings Qualifications Department of The Nasdaq Stock Market LLC (the "Listings Qualifications Department") that the Company had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market ("Nasdaq"), and is now compliant with applicable listing standards for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5550(a)(2), the Company was required to maintain a minimum closing bid price for its American Depositary Shares (the "ADSs") of $1.00 per share or more for at least 10 consecutive business days, which was achieved on September 3, 2024.

New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality

https://finance.yahoo.com/news/peer-reviewed-publication-opaganib-phase-110000409.html


Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms

The analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60%, also indicates that FiO2 of greater than 60% may represent a threshold level for disease severity, and may potentially be a patient selection biomarker, an important finding for future therapeutic strategies and studies

With 30,000 Americans dead due to COVID-19 so far this year according to the World health Organization[1], new, effective and safe therapies are still very much needed

With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles in oncology indications, viral infection, nuclear/radioprotection and other inflammatory diseases

TEL AVIV, Israel and RALEIGH, N.C., Sept. 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the publication of data, in the journal Microorganisms[2], from the 57-site, randomized, placebo-controlled, double-blind phase 2/3 study of opaganib[3] in COVID-19 pneumonia (NCT04467840).


The post hoc analysis of data from 251 study participants showed that hospitalized COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60% (FiO2≤60%) had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134). There was a clinically meaningful 62% reduction in mortality (5.98% vs. 16.7%; p-value=0.019 (post-hoc)) by day 42. Additionally, the proportion of patients with FiO2≤60% at baseline that no longer required supplemental oxygen (≥24 hours) by day 14 of opaganib treatment increased by 21% (76.9% opaganib vs. 63.4% placebo: p-value =0.033 (post hoc)). The safety profile for opaganib was similar to placebo.

The data also indicated that FiO2 of greater than 60% may represent a threshold level for disease severity which could be utilized as a biomarker, an important finding for future therapeutic strategies.

"The all-consuming COVID-19 state-of emergency may have subsided, but the SARS-CoV-2 virus has not – patients are still contracting COVID-19. 30,000 Americans have died due to COVID-19 so far this year, and many patients are still hospitalized because of it. This remains a patient population for whom there are still very limited treatment options and there remains a substantial need for effective and safe new therapies," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "These published post-hoc study data suggest a distinct treatment benefit in hospitalized COVID-19 patients requiring an FiO2 of ≤60%. This, supported by additional data such as lower inflammatory markers and higher lymphocyte counts, and added to a favorable safety profile, point to the potential of opaganib to be an effective new oral therapy for hospitalized COVID-19 patients, warranting further investigation. Of significant additional interest is the insight that baseline FiO2 requirement may be a new clinical biomarker for patient selection and potentially have a major impact on how hospitalized COVID-19 patients are managed in the future."

I some regained confidence we shall be able
to recoup some of our losses now that RDHL
seems to be on the right tracks.
Time will tell.

Midas,

Thanks for the updates; including the data on the "short interests"! I'm still hanging in there...quite a few years now...2015-16!

Scrapiron

RedHill Biopharma Ltd. (NASDAQ:RDHL) Short Interest Down 94.8% in August

https://www.modernreaders.com/news/2024/08/28/redhill-biopharma-ltd-nasdaqrdhl-short-interest-down-94-8-in-august.html

RedHill Biopharma Ltd. (NASDAQ:RDHL – Get Free Report) saw a significant drop in short interest during the month of August. As of August 15th, there was short interest totalling 21,700 shares, a drop of 94.8% from the July 31st total of 417,400 shares. Approximately 1.7% of the shares of the company are short sold. Based on an average daily trading volume, of 304,200 shares, the days-to-cover ratio is presently 0.1 days.

Hedge Funds Weigh In On RedHill Biopharma
A hedge fund recently raised its stake in RedHill Biopharma stock. Gagnon Securities LLC boosted its holdings in shares of RedHill Biopharma Ltd. (NASDAQ:RDHL – Free Report) by 32.1% in the 1st quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission (SEC). The fund owned 118,360 shares of the biotechnology company’s stock after purchasing an additional 28,771 shares during the period. Gagnon Securities LLC owned approximately 0.40% of RedHill Biopharma worth $63,000 at the end of the most recent quarter. Hedge funds and other institutional investors own 7.20% of the company’s stock.

We shall see if today's optimistically positive
PR of today will finally drive the shorts away!
Sure hope so!

RedHill Biopharma Announces First Half 2024 Business Highlights

Numerous potential catalysts

Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base

U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S. government and other collaborations

Addressing substantial and underserved indications: In oncology viral pandemic preparedness, nuclear/radioprotection, and obesity/diabetes

Building value: In the lab and in the clinic through new studies, generating new intellectual property and publications and forging the right partnerships for our assets

Streamlined U.S. commercial organization: Cost reduction measures resulted in a much smaller, more efficient and cost-effective organization while still maintaining a leadership position with Talicia®

R&D and Commercial Highlights:

Opaganib:
- U.S. Army program for Ebola (believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease)
- Orphan drug designation granted by FDA for neuroblastoma
- Discussions ongoing for a potential externally-funded, mid-stage clinical study in an additional underserved oncology indication
- U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure
- Positive in vivo study results support potential of opaganib therapy in diabetes / obesity

RHB-107:
- COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment; enrollment estimated to be completed in the first half of 2025
- U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir

RHB-104: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease

Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team:
- Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use
- Potential manufacturing developments aiming to open additional new markets underway
- Commercially launched in the UAE, triggering RedHill's eligibility for potential milestone and royalty payments; Additional ex-US partnerships under discussions

Financial highlights:

Cash balance of $8.2 million as of June 30, 2024[1]; Net revenues for the first half of 2024 totaled $2.6 million. Talicia contributed $3.5 million, down from the first half of 2023 due to a 12% reduction in U.S. prescriptions, driven by employee terminations and other cost-cutting measures. Movantik recorded negative revenues of $0.9 million, primarily due to product returns. Excluding one-time items in the first half of 2023 related to the Movantik® divestiture, the operating loss and net loss improved by $9.9 million and $9.5 million, respectively, as these cost-cutting measures significantly reduced overall expenses

Post-balance sheet date, RedHill signed a Global Termination Agreement with Movantik Acquisition Co. and others (the "Agreement"). The Agreement resulted in RedHill receiving $9.9 million in cash and gaining full control over $0.74 million in a restricted account, while assuming $12.2 million in liabilities, leading to a net balance sheet reduction of approximately $2.3 million. The Agreement ended all existing credit ties and removed the lien against Talicia

TEL AVIV, Israel and RALEIGH, N.C., Aug. 29, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its first half 2024 financial results and operational highlights, for the six months ended June 30, 2024.

"The first six months of this year have realized significant accomplishments, laying the groundwork for numerous potential upcoming catalysts. RedHill is now in possession of a promising, advancing and largely financially de-risked development pipeline designed to address substantial and underserved indications in oncology, viral pandemic preparedness, nuclear/radioprotection and diabetes and obesity-related disorders," said Dror Ben-Asher, RedHill's Chief Executive Officer. "There is no doubt that the last four years have been a challenge, primarily as a result of the pandemic's negative impact on our commercial launches in the United States in the first half of 2020. However, we have been turning the ship around and I am immensely proud of our team that works tirelessly to create opportunities, deliver on plans and create value in the lab and in the clinic through new studies, generating additional patents and publications, identifying important new indications and forging the right partnerships for our assets, while maintaining a market leadership position with Talicia. We are executing on our plans to ensure a clear value-driven focus, operational efficiency and financial streamlining with a low cost-base, as well as a strengthened cash balance and solid control over all elements of our business."

Financial results for the six months ended June 30, 2024 (Unaudited)[2]

Net Revenues for the first half of 2024 were $2.6 million, compared to $5.4 million for the first half of 2023. Talicia net revenues were $3.5 million for the six months ended June 30, 2024, compared to $5.1 million for the six months ended June 30, 2023, mainly due to a 26% decrease in gross revenues and a 9% increase in Gross-to-Net deductions, mainly from increased Medicaid rebates. In the first half of 2024, $0.5 million of net revenues came from sales in the UAE. Talicia scripts in the U.S. in the first half of 2024 were down by approximately 12%, compared to the same period in 2023, mainly due to reduced promotion and marketing following employee terminations and other cost-cutting measures in the United States. These measures had a significant positive impact on reducing expenses, as detailed below.

Movantik had negative net revenues of $0.9 million in the first half of 2024, compared to negative net revenues of $0.1 million in the first half of 2023, mainly due to returns related to sales in the second and third quarters of 2020.

Gross Profit for the first half of 2024 was $1.2 million, compared to $3 million for the first half of 2023, in line with the decrease in Net Revenues as explained above and primarily attributable to the reduction in Talicia prescriptions following employee terminations and other cost-cutting measures.

Research and Development Expenses for the first half of 2024 were $0.7 million, as compared to $2.3 million for the first half of 2023. The decrease is mainly attributable to the costs from closing the RHB-204 clinical trial, which were recognized in the first half of 2023, and to ongoing cost-reduction measures.

Selling, Marketing, and General and Administrative Expenses for the first half of 2024 were $9 million, compared to $19 million for the first half of 2023. This decrease was primarily due to downsizing the U.S. workforce following the Movantik divestiture, leading to lower payroll and related expenses, and reduced sales force expenses.

Other Income – There was no other income for the first half of 2024, as compared to $43 million of other income for the first half of 2023. The other income recognized in the first half of 2023 was comprised of (i) $35.5 million from the divestiture of Movantik and (ii) $7.5 million from transitional services fees provided to the buyer of Movantik.

Operating Loss for the first half of 2024 was $8.4 million, compared to operating income of $24.7 million for the first half of 2023. The difference is primarily attributable to the changes resulting from the divestiture of Movantik the previous year, as detailed above. Excluding the other income from the Movantik transaction in 2023, the operating loss decreased by approximately $9.9 million, from an operating loss of $18.3 million for the first half of 2023, reflecting the positive operating impact of the cost-cutting measures.

Financial Income, net for the first half of 2024 was $5.4 million, compared to $26.3 million for the first half of 2023. In the first half of 2024, the income recognized was mainly attributable to warrants' revaluation, offset by offerings' expenses. In the first half of 2023, the income recognized was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCR Collateral Management LLC debt in exchange for the transfer of rights to Movantik.

Net Loss was $3.1 million for the first half of 2024, compared to net income of $51 million for the first half of 2023. This change was primarily attributable to the effects resulting from the sale of Movantik and ongoing cost-reduction measures, as detailed above. Excluding the other income and financial income from the Movantik transaction in 2023, the net loss decreased by approximately $9.5 million, from a net loss of $12.6 million for the first half of 2023, reflecting the positive net impact of the cost-cutting measures.

Total Assets as of June 30, 2024 were $22 million, as compared to $23 million as of December 31, 2023. The decrease was primarily attributable to a reduction in the inventory balance due to sales, as well as a reduction in right-of-use assets, due to termination of car leases in the six months ended June 30, 2024.

Total Liabilities as of June 30, 2024 were $22 million, as compared to $21 million as of December 31, 2023. The increase is mainly due to higher allowance from deductions from revenues and increased warrant-related derivative liabilities, partially offset by lower accounts payable, accrued expenses and lease liabilities (due to the car leases' termination).

Net Cash Used in Operating Activities for the six months ended June 30, 2024 was $6.2 million, compared to $17.8 million for the same period in 2023. The decrease in cash used was primarily due to settling pre-closing liabilities associated with Movantik and other operational activities in the six months ended June 30, 2023. Furthermore, this reduction is attributable to the cost-cutting measures mentioned above.

Net Cash Provided by Financing Activities for the six months ended June 30, 2024 was $7.9 million, comprised primarily of the net proceeds from securities offerings in the six months ended June 30, 2024. For the six months ended June 30, 2023, Net Cash Provided by Financing Activities was $4.8 million, comprised primarily of the net proceeds from securities offerings in the six months ended June 30, 2023, and the decrease in restricted cash, partially offset by the repayment of payables related to the purchase of intangible assets.

Cash Balance as of June 30, 2024 was $8.2 million1.

R&D and Commercial Highlights:

R&D:

RedHill's pipeline is centered around opaganib[3] & RHB-107[4], two promising, potentially broad utility, novel, oral, host-directed small molecule drugs with demonstrated safety and efficacy profiles. Both candidates are advancing in predominantly U.S. government-supported, externally-funded programs, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval.

Between them, they are in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection (Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure).

Being (i) easy to administer and distribute and (ii) viral mutation-resistant, they are ideally suited for stockpiling strategies in the event of nuclear/chemical incidents and viral pandemic scenarios.

Opaganib:

U.S. Army program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability

Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology)

Discussions ongoing for a potential externally-funded, late-stage study in an additional underserved oncology indication

Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders – a market projected to be worth approximately $100 billion within the next decade

U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for ARS and Sulfur Mustard exposure

Late-stage COVID-19 program continues to address a multi-hundreds of millions of dollars market

New opaganib publications:
- The Sphingolipid-Modulating Drug Opaganib Protects against Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as a Medical Countermeasure and in Cancer Radiotherapy. Publication showed that opaganib significantly improved long-term survival in an in vivo model of lung damage following exposure to ionizing radiation[5]
- Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based Upon FiO2 Requirements. Publication showed that oral opaganib reduced mortality by 62% and delivered improved time to room air, and faster time to hospital discharge in a large group of 251 hospitalized, moderately severe COVID-19 patients requiring a Fraction of inspired Oxygen up to and including 60% (FiO2=60%). The paper also indicates that due to the lack of treatment effect in patients requiring FiO2>60%, this may represent a threshold level for disease irreversibility (likely due to more severe COVID-19 lung disease) and be an important patient selection clinical biomarker, a key finding for future therapeutic strategies and studies[6]

New Chinese patents granted for opaganib:
- In combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response. Provides protection for opaganib's potential use in combination with a range of approved and in-development ICIs across a growing range of indications through 2040
- As a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus); valid through 2035

RHB-107 (upamostat):

COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment. Enrollment is estimated to be completed in the first half of 2025

U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies

RHB-104[7]: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease

Commercial:

Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team:

Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use

Potential manufacturing developments aiming to open additional new markets underway

Now commercially launched in the UAE, triggering RedHill's eligibility for potential milestone and royalty payments

Two new U.S. patent grants covering Talicia as:
- A method for eradicating H. pylori regardless of BMI, valid until May 2042
- Use as an all-in-one treatment of H. pylori infection, valid until 2034

Shorts are back in control now. That is what happens with reverse splits and why you never ever want to do one so redhill does two of htem. Unreal.

7.90 -0.53 (-6.29%)
As of 10:12 AM EDT. Market Open.
Titanic!

And so begins the slow drip of the shorts once again destroying this stock. Its like clock work

This is a positive passage:
We also see such utility extending to the potential for opaganib to have a sensitizing effect in hormone receptor pathway inhibition therapy, which the Company expects to test in a planned externally funded Phase 2 study."
and:
may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits

RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma

https://finance.yahoo.com/news/redhills-opaganib-granted-orphan-drug-110000986.html

Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths[1],[2]

Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits

The neuroblastoma market is expected to reach almost $1.5 billion before mid-2030s[3]

This is the second orphan drug designation by the FDA for opaganib in oncology, after cholangiocarcinoma (bile duct cancer, CCA)

With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles

TEL AVIV, Israel and RALEIGH, N.C., Aug. 26, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to opaganib for treatment of neuroblastoma, a type of childhood cancer that develops from immature nerve cells and accounts for 15% of all pediatric cancer-related deaths.

Orphan Drug designation provides for a seven-year marketing exclusivity period should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits.

"RedHill is proud to have received a second orphan-drug designation for opaganib in oncology, following its previous designation for cholangiocarcinoma (CCA, also known as bile duct cancer). This designation for neuroblastoma – the most common infancy malignancy and for which new options are urgently needed – adds to opaganib's potential as a novel oncological agent," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "Opaganib has broad oncology potential with promising preliminary clinical data in solid tumor cancers such as prostate cancer and CCA, and data from a range of U.S. government supported and Apogee conducted preclinical studies in various indications, including radioprotection, and also in combination with RedHill's RHB-107. We also see such utility extending to the potential for opaganib to have a sensitizing effect in hormone receptor pathway inhibition therapy, which the Company expects to test in a planned externally funded Phase 2 study."

Neuroblastoma usually affects children aged five or younger but does also occur in older children. In the United States, approximately 650 new cases are diagnosed each year, accounting for around 10% of all childhood cancer cases. Treatment typically involves a combination of surgery, chemotherapy, radiation therapy, and sometimes targeted therapy or immunotherapy. New options are urgently needed.

The neuroblastoma market is expected to reach almost $1.5 billion before the middle of the next decade.

Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection.

About Neuroblastoma

Neuroblastoma is a type of cancer most commonly affecting babies and young children. It is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S. it accounts for up to around 10% of all childhood cancer cases. It affects around 11 to 13 kids per million children aged younger than 15 years old – with incidence rising to 65 per million in babies under one year old, equating to approximately 650 new cases each year.

Neuroblastoma originates from nerve cells called neuroblasts, which are found in the adrenal glands (located above the kidneys) and in nerve tissue along the spine, chest, abdomen, or pelvis. The exact cause of neuroblastoma is not well understood, but genetic mutations and abnormalities are known to play a role. Some cases may be linked to genetic syndromes or family history, although most occur sporadically without a clear inherited pattern.

The outlook for children with neuroblastoma can vary widely. Factors affecting prognosis include the stage of the disease at diagnosis, the age of the child, and specific biological characteristics of the tumor. Neuroblastoma is known for its ability to sometimes regress spontaneously in very young children, but it can also be aggressive and challenging to treat, accounting for 15% of pediatric cancer-related deaths.

About Opaganib (ABC294640)

Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including obesity-related syndromes, prostate cancer and cholangiocarcinoma (bile duct cancer), gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.

Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH: The Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health, for the nuclear medical countermeasures (MCM) product development pipeline selected opaganib for development as a potential treatment for Acute Radiation Syndrome (ARS); and the Chemical Medical Countermeasures (Chem MCM) Program and the Chemical Countermeasures Research Program (CCRP), managed respectively by the Administration for Strategic Preparedness and Response (ASPR) / Biomedical Advanced Research and Development Authority (BARDA) and NIH/NIAID selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure.

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.

Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

NEWS https://finviz.com/quote.ashx?t=RDHL&p=d#google_vignette

shorts were just waiting to pounce and here we go

Guessing the low float makes it harder to short and manipulate like crazy.

Well, that's a good start anyway, and the market
sure is positively noticing the company as the
rising sp indicates.
Time will tell if RDHL sp momentum continues!
I for one am cautiously optimistic!

$RDHL RedHill Biopharma

https://finance.yahoo.com/news/three-undiscovered-gems-united-states-150814759.html

Overview: RedHill Biopharma Ltd. is a specialty biopharmaceutical company that primarily focuses on gastrointestinal and infectious diseases, with a market cap of $256.99 million.

Operations: RedHill Biopharma Ltd. derives its revenue from the sale of specialty biopharmaceutical products targeting gastrointestinal and infectious diseases. The company has a market cap of $256.99 million.

RedHill Biopharma, a small cap stock, recently reported a significant one-off gain of US$54.6M for the year ending December 31, 2023. The company is debt-free and has maintained this status for over five years. Despite becoming profitable last year, its share price has been highly volatile over the past three months. Recent developments include the launch of Talicia in the UAE and positive results from studies on opaganib for Type 2 diabetes treatment.

They have some revenue but its nothing that will make wall street excited. They need something game changing at this point to get the attention of investors

9.26 +0.73 (+8.66%)
As of 10:13 AM EDT. Market Open
Cool.

Talicia sales are not very good so really they got no revenue to speak of
Talicia net revenues for the year ended December 31, 2023, increased
to $8.8 million from $7.7 million.
.....so really they got no revenue to speak of.
True, however RedHill’s R&D efforts are concentrated on its two lead investigational candidates, opaganib
and RHB-107 – with both advancing in programs that are externally funded, predominantly
through U.S. government support, and directed at multiple underserved indications that provide
both sizeable market opportunities, estimated aggregate to be well in excess of $1 billion
globally, and potentially advantageous pathways to approval.

The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales
With a Population of 9.441 million, the market is not HUGE,
but still hopefully a revenue $$$ stream a-coming!

Talicia® Launched in the United Arab Emirates

https://finance.yahoo.com/news/talicia-launched-united-arab-emirates-110000964.html
In this article:

RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H. pylori infection in the United Arab Emirates (UAE)

The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales

Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[1] for the treatment of H. pylori, a bacterial infection that affects 41% of the UAE population[2] and over 50% of the world's adult population[3]

RALEIGH, N.C., Aug. 21, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the launch of Talicia (omeprazole magnesium, amoxicillin and rifabutin)[4] in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori (H. pylori) infection. The commercial launch of Talicia in the UAE triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori.

"We are delighted with the commercial launch of Talicia in the UAE, bringing this important medicine to patients in the region," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer. "As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern. With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies[5],[6], there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners."

Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[7]. Clarithromycin-based treatment efficacy can also be negatively impacted by patient obesity or diabetic status, neither of which impact Talicia's safety or efficacy, according to data from post-approval post-hoc analysis[8],[9].

About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[10] of the U.S. population, with an estimated two million patients treated annually[11]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[12] and a major risk factor for peptic ulcer disease[13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[14]. More than 27,000 Americans are diagnosed with gastric cancer annually[15]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[16].

About Talicia
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[17] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[18].
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (=1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com

About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[19], and Aemcolo®, for the treatment of travelers' diarrhea in adults[20]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.

More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.

Not saying it wont happen but more likely why has it not happened. I mean especially when they are desperate for money you would think somebody could cut a deal with them for a steal.

why is nobody partnering with them or giving them any money?
A matter of time imo and with a number of partners/sponsers.
For this reason i am still here albeit very deep underwater,with
dim hopes to recover some of my losses.

8.21 +0.18 (+2.22%)
As of 1:46 PM EDT. Market Open.
This i did not expect!!!

But again if all these studies were so great why is nobody partnering with them or giving them any money? Talicia sales are not very good so really they got no revenue to speak of. I fear now with the price higher they are ready for a big fat offering.

7.98 -0.05 (-0.59%)
As of 11:36 AM EDT. Market Open.
Now, that is a very pleasant surprise.

They got nothing
True. What RDHL really needs is a
steady revenue $$$ stream.

If there was any good news it would have been released to avoid the split. They got nothing.

What good news all we get is fulff on studies followed by dilution. If the results of any of these studies were so great somebody would parnter with them or give them money. Yet nobody does which tells me its just pr bs to drive up the stock price before the offering, etc. I am pretty much done at this point. I dont have any faith in them anymore. Kicking myself for not selling it all before today as I knew I should have. This stock will be 4 bucks within a month.

Unless some good news, RDHL
is doomed!

as expected stock gettting crushed after the split.I dont short but if i did would have been a very easy short.

That is what they always do after a reverse split. Reverse splits almost never ever work out all they do is crush shareholders. Look at the last reverse split was done at 5 bucks and we went down to .30 cents. Shorts have a total field day with a reverse split and a company should never ever do one unless they they have zero other options.

Why are people / sellers are selling shares so cheap! Sellers are creating drop of the price / chaos. Weak sellers we have!

Just a t typical rdhl pump before tomorrow. Once the split happens the shorts will tank this thing very fast. If they had any real good news they would have already released it to avoid the reverse split. Simply rinse and repeat

"Opaganib, which acts as a sphingosine competitor, is the first
clinical drug to target three key enzymes in this pathway."
Great news once it gets into the market!
What RDHL urgently needs is some steady
$$$ revenue stream!

https://x.com/viewmont12/status/1825502196617908378