Welcome to our dedicated page for Relmada Therapeutics news (Ticker: RLMD), a resource for investors and traders seeking the latest updates and insights on Relmada Therapeutics stock.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) is a clinical-stage biotechnology company whose news flow centers on the development of NDV-01 for non-muscle invasive bladder cancer (NMIBC) and sepranolone for central nervous system conditions. Company press releases frequently highlight clinical data readouts, regulatory interactions, and financing events that shape the outlook for its pipeline.
Recent news has focused on NDV-01, a sustained-release, intravesical formulation of gemcitabine and docetaxel in development for NMIBC. Relmada has reported 6‑month and 9‑month follow-up data from an open-label Phase 2 study, including complete response rates at various time points, safety findings, and outcomes such as absence of progression to muscle-invasive disease and lack of radical cystectomy among reported patients. Updates also describe treatment-related adverse events and their severity profile.
Another key theme in RLMD news is FDA regulatory feedback. The company has announced written guidance from the FDA supporting two potential registrational study paths for NDV-01: a single-arm trial in high-grade, 2nd-line BCG-unresponsive NMIBC with carcinoma in situ and a randomized-to-observation trial in intermediate-risk NMIBC in the adjuvant setting. These items are often accompanied by timelines for anticipated Phase 3 trial initiation and expectations around a 505(b)(2) regulatory pathway.
Relmada’s news feed also covers corporate and financial updates, including quarterly financial results, underwritten equity offerings, Nasdaq listing compliance notices, and additions to its clinical advisory board. For sepranolone, press releases describe its GABAA-modulating mechanism and planned Phase 2 development in Prader-Willi syndrome and other compulsivity-related disorders. Investors monitoring RLMD news can use this page to follow clinical milestones, regulatory developments, capital-raising activities, and other disclosures that the company furnishes through GlobeNewswire and SEC-related announcements.
Relmada Therapeutics (Nasdaq: RLMD) announced the presentation of data on its lead product candidate, REL-1017, at the ASPET Annual Meeting, which runs virtually from April 27 to April 30, 2021. The poster titled, REL-1017 (esmethadone) Did Not Produce Initial or Cumulative Neurotoxic Effects, highlights REL-1017's safety profile and its potential as a rapid-acting antidepressant. Previously, REL-1017 received FDA Fast Track designation for treating major depressive disorder (MDD) as an adjunctive treatment following positive Phase 2 trial results.
Relmada Therapeutics (Nasdaq: RLMD) has initiated the second pivotal Phase 3 trial of its lead candidate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), which affects over 17 million Americans. The RELIANCE program consists of two studies, each targeting 364 patients who have not adequately responded to standard antidepressants. Primary outcomes will be measured by the Montgomery and Asberg Depression Rating Scale (MADRS) at day 28. Top-line data from both trials is expected in the first half of 2022, building on promising results from a previous Phase 2 trial.
Relmada Therapeutics (Nasdaq: RLMD) announced its fourth quarter and full year 2020 financial results, reporting a net loss of $20.8 million for Q4 and $59.5 million for the year. The company is advancing its lead candidate, REL-1017, intended for major depressive disorder (MDD). Following a successful Phase 2 trial, the Phase 3 program is underway, with the first trial, RELIANCE I, actively enrolling patients. Relmada has significant cash reserves of approximately $117.1 million, which is projected to support upcoming studies and milestones into 2022.
Relmada Therapeutics (Nasdaq: RLMD) will report its fourth quarter and full-year financial results for 2020 on March 23, 2021, after market close. This announcement precedes a conference call and live audio webcast scheduled for the same day at 4:30 PM ET. The company focuses on central nervous system diseases, particularly major depressive disorder, with its lead program, REL-1017, in late-stage development. A replay of the webcast will be accessible on their Investor Relations page.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 10:40 a.m. ET. A live webcast will be available on the investor section of the company's website, with a replay accessible for 90 days post-event.
Relmada focuses on central nervous system diseases, particularly major depressive disorder, and is advancing its lead program, REL-1017, into late-stage development.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the 2021 SVB Leerink Global Healthcare Conference on February 25, 2021, at 3:40 p.m. ET. The event will be webcast live, with a replay available for 90 days. Relmada focuses on addressing central nervous system diseases, particularly major depressive disorder (MDD), with its lead program, REL-1017, in late-stage development as an adjunctive treatment for MDD in adults. The press release includes forward-looking statements regarding risks and uncertainties.
Relmada Therapeutics (Nasdaq: RLMD) announced the enrollment of the first patient in its Phase 3 trial (RELIANCE I) for REL-1017 as an adjunctive treatment for major depressive disorder (MDD). CEO Sergio Traversa highlighted this as a significant milestone, emphasizing guidance from the FDA based on positive Phase 2 results. The Phase 3 program features two trials involving 400 MDD patients across 55 sites in the U.S. Key endpoints include assessing changes in depression scores at day 28, with top-line results expected in the first half of 2022.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) will have its CEO, Sergio Traversa, participate in two virtual investor conferences. The first is the Jefferies London Healthcare Conference on November 19, 2020, at 10:50 AM EST, with a live webcast available on their website. The second is the Piper Sandler 32nd Annual Healthcare Conference, where a fireside chat will be accessible starting November 23, 2020. Relmada specializes in therapies for CNS diseases, focusing on major depressive disorder (MDD) with its lead program REL-1017.
Relmada Therapeutics (Nasdaq: RLMD) has expanded its leadership with the appointments of Paolo Manfredi, M.D., as Acting Chief Scientific Officer and Marco Pappagallo, M.D., as Acting Chief Medical Officer. Both bring extensive experience in CNS therapies. The company is on track to start its pivotal Phase III trial of REL-1017 for major depressive disorder (MDD) by Q4 2020, along with other significant milestones planned for 2021, including human abuse potential studies and additional trials. REL-1017 has demonstrated promising results in previous studies.
Relmada Therapeutics (Nasdaq: RLMD) received a Notice of Allowance from the Canadian Intellectual Property Office for its patent on REL-1017, a novel NMDA receptor antagonist. This patent broadens its intellectual property in Canada, a key market for treating psychological disorders such as depression and anxiety. The company is set to initiate its Phase 3 program for REL-1017 in Q4 2020 after receiving FDA clearance to proceed without further trials. REL-1017 showed promising Phase 2 results, demonstrating significant antidepressant effects and a favorable safety profile.