iHub News
3月前
Relmada Therapeutics shares jump 25% after promising bladder cancer trial resultsMarch 9, 2026 9:51 AM
IH Market News
Shares of Relmada Therapeutics, Inc. (NASDAQ:RLMD) climbed 25% on Monday after the company released 12-month interim results from its Phase 2 study of NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).The trial reported a 12-month complete response (CR) rate of 76%, while 95% of patients achieved a complete response at some point during the study. Among patients whose disease was unresponsive to BCG therapy, the 12-month CR rate reached 80%, with 94% achieving CR at any time.According to the company, none of the treated patients experienced progression to muscle-invasive disease or required radical cystectomy. The treatment also showed a favorable safety profile, with no treatment-related adverse events of Grade 3 or higher and no patients discontinuing therapy because of side effects.Of the 48 patients who received at least one dose of NDV-01, 30 (63%) experienced a treatment-related adverse event. The most frequently reported event was dysuria, occurring in 54% of patients. Additionally, 8% experienced asymptomatic positive urine cultures and another 8% reported hematuria.Relmada said it intends to move NDV-01 into its Phase 3 RESCUE registrational program by mid-2026, focusing on two potential indications: second-line treatment for BCG-unresponsive NMIBC and adjuvant therapy for intermediate-risk NMIBC. The company estimates that the intermediate-risk NMIBC market includes about 75,000 patients annually in the United States, while roughly 5,000 patients each year are diagnosed with BCG-unresponsive NMIBC with carcinoma in situ.Relmada also announced plans for a private investment in public equity (PIPE) financing expected to raise approximately $160.0 million in gross proceeds. The company is offering 29,474,569 shares of common stock at $4.75 per share, along with pre-funded warrants to purchase 4,210,527 shares priced at $4.749 per warrant. The financing is expected to close on or around March 11, 2026.Jefferies, Leerink Partners, Piper Sandler and Mizuho are serving as placement agents for the transaction.Relmada Therapeutics stock price
Original: Relmada Therapeutics shares jump 25% after promising bladder cancer trial results
US Market News
3月前
Psychedelic Medicine Advances: Here Are Five Companies Targeting CNS DisordersFebruary 26, 2026 12:07 PM
PR Newswire (US)
Issued on behalf of Helus PharmaVANCOUVER, BC, Feb. 26, 2026 /PRNewswire/ -- USA News Group News Commentary – The first psilocybin compound to achieve two positive Phase 3 results in treatment-resistant depression cleared that milestone this week, signaling a potential shift in how regulators and investors view psychedelic-based psychiatry[1]. The pathway is widening at the federal level, where the Drug Enforcement Administration raised its 2026 psilocybin production quota by 67%[2]. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), Relmada Therapeutics (NASDAQ: RLMD), Alto Neuroscience (NYSE: ANRO), and Axsome Therapeutics (NASDAQ: AXSM).
The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity[3]. The pipeline is moving to meet it, and the capital is following.Helus Pharma (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing treatments for depression and anxiety. Its approach centers on novel serotonergic agonists, synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity.Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026, pronounced "Heal-Us," and began trading on the NASDAQ under the ticker HELP. The name reflects its transition toward a commercial-ready pharmaceutical operation.The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. It operates across Canada, the United States, the United Kingdom, and Ireland.Recently, Nature Medicine published results from a randomized, placebo-controlled Phase 2a trial of SPL026 in patients with moderate-to-severe major depressive disorder. The study enrolled 34 participants across three clinical sites in the United Kingdom.The study met its primary endpoint. Participants receiving a single 21.5 mg dose showed a mean MADRS difference of -7.35 versus placebo (p=0.023), with effects appearing within one week (p=0.002).Response rates at two weeks reached 35% versus 12% for placebo. Remission rates were 29% versus 12%.Effects were sustained for up to three months, with some participants maintaining improvements for up to six months. No treatment-related serious adverse events were reported."The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility," said Michael Cola, CEO of Helus Pharma.HLP004, a proprietary intramuscular compound informed by the SPL026 clinical insights, is now in Phase 2 for generalized anxiety disorder. Helus expects topline data from that study this quarter.The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder.Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores.The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress.Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline.CONTINUED… Read this and more news for Helus Pharma at:https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/ In other industry developments:Compass Pathways (NASDAQ: CMPS) this week reported positive results from two pivotal Phase 3 trials evaluating COMP360, a synthetic psilocybin compound, in patients with treatment-resistant depression. The larger trial, COMP006, enrolled 581 participants across international sites and demonstrated a highly statistically significant reduction in symptom severity, with a p-value below 0.001 and a mean treatment difference of 3.8 points on the MADRS depression scale at Week 6.The company has submitted a request to the FDA to discuss a rolling submission and review, a pathway that could shorten the timeline to a potential approval filing. Across both Phase 3 studies, 39% of participants receiving the 25 mg dose achieved a clinically meaningful reduction in depression scores at Week 6, with durable effects observed through 26 weeks after just one or two administrations.COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression, a condition that affects roughly one-third of patients who do not respond to standard antidepressants. Most treatment-emergent adverse events were mild or moderate, with the vast majority resolving within 24 hours. The company expects 26-week durability data from COMP006 in early Q3 2026.Relmada Therapeutics (NASDAQ: RLMD) in January confirmed that the FDA has aligned on the registrational development pathway for NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. The agency indicated that a single-arm, open-label pivotal trial is appropriate for second-line refractory high-grade patients with carcinoma in situ, one of the most treatment-resistant bladder cancer populations."A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives," said Raj S. Pruthi, MD, Chief Medical Officer at Relmada Therapeutics. "This study represents the fastest path to approval for NDV-01."The company anticipates initiating both registrational trials in the first half of 2026. NDV-01 is designed to be administered in-office in under five minutes without anesthesia or specialized equipment, with bladder retention and gradual drug release over ten days. Non-muscle invasive bladder cancer represents 75% to 80% of all bladder cancer cases, with over 744,000 prevalent cases in the United States and recurrence rates of 50% to 80% over five years.Alto Neuroscience (NYSE: ANRO) recently completed enrollment in its Phase 2 proof-of-concept trial of ALTO-101, a novel transdermal PDE4 inhibitor for cognitive impairment associated with schizophrenia. The randomized, double-blind, placebo-controlled crossover study enrolled 83 patients across 13 clinical sites in the United States, with topline data expected around the end of Q1 2026."This milestone brings us closer to potentially delivering a first-of-its-kind treatment for the millions of patients suffering from the debilitating cognitive effects of schizophrenia," said Amit Etkin, MD, PhD, founder and CEO of Alto Neuroscience. "Our baseline results have already replicated findings from three independent datasets, reinforcing our confidence in ALTO-101's mechanism and our biomarker-driven approach."There are currently no approved pharmacologic treatments for cognitive impairment in schizophrenia, a condition affecting nearly all patients with the disorder and a primary driver of long-term functional disability. ALTO-101 is delivered through a proprietary transdermal system developed with MEDRx, designed to reduce the gastrointestinal side effects common to oral PDE4 inhibitors while maintaining central nervous system target engagement. The FDA has granted ALTO-101 Fast Track Designation for this indication.Axsome Therapeutics (NASDAQ: AXSM) in December announced that the FDA has accepted and granted Priority Review to its supplemental New Drug Application for AXS-05, a novel NMDA receptor antagonist and sigma-1 agonist, for the treatment of Alzheimer's disease agitation. The PDUFA target action date is April 30, 2026."Up to 76% of people with Alzheimer's disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments," said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. "We look forward to continuing to work with the FDA for the remainder of the review."AXS-05 previously received FDA Breakthrough Therapy designation for Alzheimer's agitation in 2020 and is already approved in the United States as Auvelity for the treatment of major depressive disorder in adults. The supplemental NDA is supported by four randomized, double-blind, controlled Phase 3 trials and a long-term safety study. Approximately 7 million Americans live with Alzheimer's disease, and the company's patent estate for AXS-05 extends through at least 2043.Article Source: https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/ CONTACT:USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/https://www.federalregister.gov/documents/2026/01/05/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessmenthttps://www.who.int/news/item/02-09-2025-over-a-billion-people-living-with-mental-health-conditions-services-require-urgent-scale-upLogo - https://mma.prnewswire.com/media/2838876/5826124/USA_News_Group_Logo.jpg
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Original: Psychedelic Medicine Advances: Here Are Five Companies Targeting CNS Disorders
INV4
9月前
RELMADA THERAPEUTICS CEO Sergio Traversa Acquires 265,976 Shares
August 28, 2025
Sergio Traversa, Chief Executive Officer and Director at RELMADA THERAPEUTICS, purchased a total of 265,976 common stock shares over three transactions dated from August 26 to August 28, 2025. The purchases were made at weighted average prices of $0.62, $0.67, and $0.74 respectively, with a total investment of $178,094. Following these transactions, Traversa directly owns 1,000,000 shares of RELMADA THERAPEUTICS.
SEC Filing: RELMADA THERAPEUTICS, INC. [ RLMD ] - Form 4 - Aug. 28, 2025
Link SEC filing
https://www.tradingview.com/news/tradingview:df659300b4962:0-relmada-therapeutics-ceo-sergio-traversa-acquires-265-976-shares/
$RLMD
Paulness
6年前
NEWS -- Relmada Therapeutics Announces Initiation of Phase 3 Program for REL-1017 as Adjunctive Treatment for Patients with Major Depressive Disorder
NEW YORK, Dec. 7, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that the first patient has been enrolled in the first Phase 3 clinical trial (RELIANCE I) for the Company's lead product candidate, REL-1017, as an adjunctive treatment for major depressive disorder (MDD).
"The initiation of our Phase 3 program for REL-1017 represents a significant operational milestone for our company," said Sergio Traversa, CEO of Relmada Therapeutics. "Importantly, the design of the Phase 3 program incorporates valuable guidance from the U.S. Food and Drug Administration (FDA) obtained in our successfully completed End-of-Phase 2 meeting. We believe that the reported positive Phase 2 results are indicative of the potential of REL-1017 to treat patients suffering from MDD. We look forward to the availability of top-line results from RELIANCE I in the first half of 2022."
"A significant unmet medical need continues to exist for therapeutics that demonstrate a rapid and robust antidepressant effect in patients with MDD, especially for patients who do not respond adequately to their first line of treatment. We are hopeful for the results of the RELIANCE trials and that in the near future physicians will have access to this novel treatment in their armamentarium " said Maurizio Fava, M.D., Chief of the Department of Psychiatry at Massachusetts General Hospital, and Principal Investigator for the REL-1017 Phase 3 program. "This important Phase 3 program provides us with an opportunity to confirm and further show the effect of REL-1017 in the treatment of MDD, a devastating and life altering condition with many sequelae. I am inspired and excited to continue evaluating this promising product candidate in late-stage clinical trials" said Marco Pappagallo, M.D. acting Chief Medical Officer of Relmada Therapeutics.
Key points of the Phase 3 program agreed upon in discussions with FDA include:The Phase 3 program will consist of two sister, two-arm, placebo-controlled clinical trials. Each trial will be conducted in 55 clinical sites in the United States and will include approximately 400 MDD patients with inadequate response to standard antidepressants in their current depression episode. Patients will add either a 25 mg oral dose of REL-1017 once per day or placebo to their ongoing antidepressant treatment.The primary endpoint to be evaluated will be the change from baseline on the Montgomery and Asberg Depression Rating Scale (MADRS) score at day-28 for REL-1017 compared to placebo. Success on this endpoint with the collection of sufficient safety data would support the use of REL-1017 for chronic treatment, if approved.The change from baseline and the 7-day MADRS score will serve as a key secondary endpoint and will provide data on the rapid onset of treatment effect; statistically significant separation between REL-1017 and the control group was achieved by day 4 in the Phase 2 proof-of-principle trial completed in 2019.The Company expects to initiate the second Phase 3 trial, RELIANCE II, in the first half of 2021. Patients who complete RELIANCE I and RELIANCE II will be eligible to rollover into the long-term, open-label study, which is also expected to include subjects who had not previously participated in a REL-1017 clinical trial.Upcoming anticipated milestones for REL-1017 include:1H21 – Start of RELIANCE II, the second pivotal Phase III adjunctive MDD trial1H21 – Start of Phase II monotherapy MDD trial2Q21 – Results of human abuse potential studies4Q21 – Results of Phase II monotherapy MDD trial1H22 – Results of RELIANCE I and RELIANCE II adjunctive MDD trialsAbout REL-1017
REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is entering late-stage studies as an adjunctive treatment for MDD in adults. Our clinical program for REL-1017 will evaluate its potential as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for REL-1017 for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive treatment for MDD in adults.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "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, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
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SOURCE Relmada Therapeutics, Inc.
Paulness
6年前
NEWS -- Relmada Therapeutics to Participate in Upcoming Investor Conferences
NEW YORK, Nov. 17, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Sergio Traversa, Chief Executive Officer of Relmada, will participate in the following upcoming virtual investor conferences:
Jefferies London Healthcare Conference
Date: Thursday, November 19, 2020
Time: 10:50 AM EST/3:50 PM GMT
Webcast: A live webcast of the fireside chat will be available by visiting the "Investors" section of the company's website: HTTP://www.relmada.com. A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.
Piper Sandler 32nd Annual Healthcare Conference
Management will participate in a fireside chat, which will be accessible beginning on November 23, 2020, via the "Investors" section of the company's website: HTTP://www.relmada.com. The link will remain active for 90 days thereafter.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage pharmaceutical company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, and is entering late-stage studies as an adjunctive treatment for MDD in adults.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-to-participate-in-upcoming-investor-conferences-301174575.html
SOURCE Relmada Therapeutics, Inc.
Paulness
6年前
NEWS -- Relmada Therapeutics Expands R&D Team, Appoints Paolo Manfredi, M.D., as Acting Chief Scientific Officer, Marco Pappagallo, M.D., as Acting Chief Medical Officer and Updates R&D Milestones
NEW YORK, Oct. 27, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the expansion of its leadership team with the appointments of Paolo Manfredi, M.D., as Acting Chief Scientific Officer and Marco Pappagallo, M.D., as Acting Chief Medical Officer. The Company also provided an update of upcoming milestones for the REL-1017 program.
Dr. Manfredi has been the co-founder of Medeor, Inc. (now merged into Relmada), for which he also served as Scientific Director and co-inventor of REL-1017. Prior to this, Dr. Manfredi was an Assistant Professor in Neurology and Neuroscience at the Weill Medical College of Cornell University and served as the Fellowship Director of the Pain and Palliative Care Program at Memorial Sloan Kettering Cancer Center. Dr. Manfredi earned his Doctor of Medicine at the University of Genoa, Italy, completed his residency in neurology at Albert Einstein College of Medicine and completed several postdoctoral training fellowships, including a pain management fellowship at Massachusetts General Hospital and Harvard University.
Dr. Pappagallo most recently served as Chief Medical Officer at CerSci Therapeutics, a privately-held biotech company focused on developing pain therapeutics that was recently acquired by ACADIA Pharmaceuticals. Prior to this, he held the role of Medical Expert-in-Residence and Executive Director of Medical Intelligence at Grünenthal - USA. Dr. Pappagallo previously served as the co-founder and Chief Medical Officer of NovaPharm Therapeutics. Dr. Pappagallo served in a number of senior roles at leading medical institutions, including as the Director of Chronic Pain in the Department of Pain and Palliative Care at Beth Israel Medical Center and Professor and Director of Pain Research in the Department of Anesthesiology at Mount Sinai Medical Center. Dr. Pappagallo completed his medical school and post-graduate training in neurosurgery at the University of Rome, Italy. Subsequently, he completed his neurology residency training at the State University of New York at Stony Brook and was a clinical and research fellow in pain medicine at John Hopkins University.
Relmada also provided an R&D milestone update, as the company continues to be on track to start its first pivotal Phase III trial of REL-1017 for the adjunctive treatment of major depressive disorder (MDD) in the fourth quarter of 2020. Also, this quarter, the company expects to begin its human abuse potential studies of REL-1017. Other anticipated milestones for REL-1017 in 2021 include:1H21 – Start of second pivotal Phase III adjunctive MDD trial1H21 – Start of Phase II monotherapy MDD trial2Q21 – Results of human abuse potential studies4Q21 – Results of Phase II monotherapy MDD trial1H22 – Results of Phase III adjunctive MDD trials"We are delighted to welcome Dr. Manfredi and Dr. Pappagallo to Relmada' s leadership team. Dr. Manfredi was the co-founder of Medeor, Inc., now merged into Relmada. As a co-inventor of our core technology, Dr. Manfredi's deep insight and expertise will continue to be invaluable in the further clinical development of our lead product candidate, REL-1017," said Sergio Traversa, Chief Executive Officer of Relmada. "Dr. Pappagallo brings over 30 years of medical expertise in neurology medicine. With his significant experience directing clinical programs and passion for addressing significant medical unmet needs, Dr. Pappagallo will be instrumental in shaping Relmada' s future clinical development strategy and execution. We look forward to the significant contributions of both of these world-renowned medical experts. We are also quite excited to provide our milestone update, which highlights our team's robust progress, as we continue to advance REL-1017's late-stage development."
"I am delighted to expand my commitment to Relmada to oversee its research programs as Acting Chief Scientific Officer and lead the scientific development of REL-1017, a compound with which I am extremely familiar and I look forward to advancing this innovative treatment," said Dr. Manfredi.
Dr. Pappagallo commented, "I am excited about joining a team focused on addressing diseases of the CNS with innovative approaches, and most importantly to help the millions of people who continue to need new options for the treatment of MDD. I look forward to leading the next and last phase of clinical development of REL-1017, as an adjunctive as well as front line monotherapy treatment of MDD, as we progress our development program."
About REL-1017
REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is entering late-stage studies as an adjunctive treatment for MDD in adults. In addition to safety and efficacy, our clinical program for REL-1017 will evaluate its potential as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for REL-1017 for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage pharmaceutical company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, and is entering late-stage studies as an adjunctive treatment for MDD in adults.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "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, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
mailto://relmada@fischtankpr.com
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SOURCE Relmada Therapeutics, Inc.
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