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) reported FDA feedback supporting two potential registrational Phase 3 paths for NDV-01 in non‑muscle invasive bladder cancer: a single‑arm registrational trial in high‑grade, 2nd‑line BCG‑unresponsive patients and a randomized controlled adjuvant trial in intermediate‑risk NMIBC. FDA minutes indicated no additional non‑clinical studies are required to support a 505(b)(2) NDA. Relmada expects to begin Phase 3 programs in H1 2026. Relmada also reported Phase 2 9‑month follow‑up: 92% overall response anytime (23/25), 85% CR at 9 months (17/20), no progression to muscle‑invasive disease, no radical cystectomies, and no ≥Grade 3 treatment‑related adverse events.
Relmada Therapeutics (Nasdaq: RLMD) appointed Max Kates, MD, Associate Professor of Urology and Oncology at Johns Hopkins, to its Clinical Advisory Board to support development of NDV-01 for non‑muscle invasive bladder cancer. Relmada plans to initiate the Phase 3 NDV-01 program in H1 2026. Management cited Dr. Kates’ experience chairing the Phase 3 BRIDGE trial and high‑volume urologic practice insights as valuable to trial design and real‑world applicability. The company noted that initial safety and efficacy data for NDV-01 were presented at the American Urologic Association in April 2025 and updated in August 2025.
Relmada Therapeutics (NASDAQ:RLMD), a clinical-stage biotech company focused on oncology and CNS therapies, has successfully regained compliance with Nasdaq's minimum bid price requirement. The company received confirmation from Nasdaq on September 15, 2025, after maintaining a closing bid price of at least $1.00 for 10 consecutive business days through September 12, 2025.
This development ensures RLMD's continued listing on the Nasdaq Capital Market, as the company now meets all Nasdaq listing requirements.
Relmada Therapeutics (NASDAQ: RLMD) has issued a mid-year CEO letter highlighting significant developments in 2025. The company has expanded its portfolio with two Phase 2 candidates: NDV-01 for non-muscle invasive bladder cancer (NMIBC) and Sepranolone for compulsivity disorders.
NDV-01 demonstrated impressive 91% complete response rate in Phase 2 six-month follow-up data. The company plans to initiate Phase 3 trials in H1 2026. To strengthen the program, Relmada appointed Dr. Raj S. Pruthi as CMO-Oncology and Dr. Yair Lotan as Clinical Advisory Board Chair.
For Sepranolone, following positive proof-of-concept data in Tourette's syndrome, Relmada plans to begin Phase 2 trials for Prader-Willi Syndrome in H1 2026, targeting a population of 350,000-400,000 patients worldwide.
Relmada Therapeutics (NASDAQ:RLMD) reported significant progress in its Q2 2025 financial results and clinical developments. The company announced impressive 6-month follow-up data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), showing a 91% overall response rate with favorable safety profiles. No patients progressed to muscle invasive disease or required radical cystectomy.
Financial results showed reduced losses, with Q2 2025 net loss at $9.9 million ($0.30 per share) compared to $17.8 million in Q2 2024. The company maintained $20.6 million in cash and equivalents as of June 30, 2025. Relmada plans to initiate a Phase 3 registration trial for NDV-01 in 1H 2026 and advance sepranolone into Phase 2 studies for Prader-Willi syndrome.
Relmada Therapeutics (NASDAQ:RLMD), a clinical-stage biotechnology company focused on oncology and central nervous system therapies, will host a conference call and webcast on Thursday, August 7, 2025, at 4:30 PM ET to discuss Q2 2025 financial results and business updates.
The conference call will be accessible via US dial-in (1-877-407-0792) and International dial-in (1-201-689-8263) with conference code 13754263. A webcast replay will be available in the Investors section of Relmada's website.
Relmada Therapeutics (NASDAQ:RLMD) has appointed renowned urologic oncologist Dr. Yair Lotan as Chair of its Clinical Advisory Board (CAB). Dr. Lotan, with over 20 years of experience in bladder cancer care and clinical development, will support the advancement of NDV-01, the company's treatment for non-muscle invasive bladder cancer (NMIBC).
The appointment comes as Relmada prepares to initiate a Phase 3 trial for NDV-01 in H1 2026, following positive Phase 2 data presented at AUA 2025. NDV-01's ready-to-use sustained release formulation aims to improve upon the current gemcitabine/docetaxel combination treatment by offering easier administration outside hospital settings.
Relmada Therapeutics (NASDAQ: RLMD), a clinical-stage biotechnology company, has scheduled its first quarter 2025 financial results conference call and webcast for Monday, May 12, 2025, at 4:30 PM ET. The event will cover financial performance for Q1 ending March 31, 2025, and provide updates on recent business developments.
Investors can access the conference via US dial-in (1-877-407-0792) or International dial-in (1-201-689-8263) using conference code 13753596. A webcast replay will be available in the Investors section of Relmada's website.