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) 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.