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 strong Phase 2 NDV-01 data and completed a $160 million PIPE financing to fund development through 2029. Key clinical results showed a 95% CR rate at any time and a 76% durable CR at 12 months in high‑risk NMIBC.
The company is aligned with the FDA on two registrational pathways and plans to initiate the Phase 3 RESCUE program in mid‑2026, with IND clearance targeted the same period.
Relmada Therapeutics (Nasdaq: RLMD) will host a conference call and webcast on Thursday, March 19, 2026 at 4:30 PM ET to discuss fourth-quarter results for the period ended December 31, 2025 and recent business progress.
Participant dial-ins are provided for US and international callers, and a replay will be available in the Investors section of the Relmada website.
Relmada Therapeutics (Nasdaq: RLMD) will present at the Leerink Partners Global Healthcare Conference in Miami on March 10, 2026. CEO Sergio Traversa and CFO Maged Shenouda will participate in a fireside chat at 8:40 AM ET, with management available for one-on-one investor meetings.
The live webcast is accessible via the company Events page and an archived replay will be available for 90 days after the event.
Relmada Therapeutics (Nasdaq: RLMD) announced an oversubscribed private placement expected to raise approximately $160.0 million gross, before placement agent fees and offering expenses. The financing consists of 29,474,569 common shares at $4.75 and 4,210,527 pre-funded warrants at $4.749.
The pre-funded warrants carry a $0.001 exercise price. Closing is expected on or about March 11, 2026, subject to customary conditions. Proceeds will be used for working capital and advancing R&D. The company agreed to file resale registration rights.
Relmada Therapeutics (Nasdaq: RLMD) reported 12-month Phase 2 interim data for NDV-01 in high-risk non-muscle invasive bladder cancer. The study showed a 12-month complete response (CR) rate of 76% overall and 80% in BCG-unresponsive patients, with 95% and 94% CR rates at any time, respectively. No patients progressed to muscle-invasive disease or required radical cystectomy. No ≥ Grade 3 treatment-related adverse events or treatment discontinuations were reported. Relmada plans IND clearance and initiation of the Phase 3 RESCUE program in mid-2026, with initial Phase 3 3-month readouts expected by year-end 2026.
Relmada Therapeutics (Nasdaq: RLMD) announced FDA written feedback supporting its registrational development pathway for NDV-01 in two separate non-muscle invasive bladder cancer (NMIBC) indications.
The FDA indicated a single-arm, open-label registrational trial is appropriate for 2nd-line refractory, high-grade BCG-unresponsive NMIBC with carcinoma in situ (CIS). The agency also provided supportive written feedback for a single randomized-to-observation registrational trial in intermediate-risk NMIBC in the adjuvant setting. Relmada expects to initiate both Phase 3 registrational trials in 1H 2026.
Relmada Therapeutics (Nasdaq: RLMD) will present 6-month follow-up data from its ongoing Phase 2 study of NDV-01, a sustained‑release intravesical formulation of gemcitabine/docetaxel (Gem/Doce), at the Society of Urologic Oncology 26th Annual Meeting on Dec 4, 2025 (Poster #143, 2:30 PM MT).
The company reported favorable overall safety at six months, highlighted a previously announced 92% complete response (CR) rate at any time point in 9‑month data, and said it plans to advance NDV-01 into Phase 3 studies in two NMIBC indications in H1 2026. Relmada is targeting high‑risk and intermediate‑risk NMIBC, which it says represent about 80% of new NMIBC cases (~54,000 people in the US annually). A copy of the poster will be posted on Relmada's Events page after the session.
Relmada Therapeutics (Nasdaq: RLMD) reported Q3 2025 results and pipeline updates on Nov 13, 2025, highlighting a 92% complete response rate (anytime) at 9-month follow-up for NDV-01 in NMIBC and favorable safety.
The company secured FDA alignment on Phase 3 pathways with two potential registrational routes (high-risk 2nd-line BCG-unresponsive single-arm and intermediate-risk adjuvant randomized trial) and expects to initiate studies in H1 2026. Relmada closed an underwritten offering on Nov 5, 2025 providing approximately $100M gross proceeds and said available cash including offering proceeds should support operations into 2028.
Relmada Therapeutics (Nasdaq: RLMD) said it will report third quarter 2025 financial results and recent business progress on Thursday, November 13, 2025 at 4:30 PM ET via a conference call and webcast.
Participant dial-in numbers are US: 1-877-407-0792 and International: 1-201-689-8263. A webcast replay will be available in the Investors section at https://www.relmada.com/investors/ir-calendar.
Relmada Therapeutics (NASDAQ: RLMD) priced an underwritten offering to raise approximately $100 million in gross proceeds by selling 40,142,000 common shares and, in lieu of shares to certain investors, pre-funded warrants to purchase up to 5,315,000 common shares.
Common shares priced at $2.20 each; pre-funded warrants priced at $2.199 each (reflecting a $0.001 exercise price). The offering is expected to close on November 5, 2025, subject to customary closing conditions. Institutional investors participated and Jefferies, Leerink Partners and Mizuho acted as book-runners. Net proceeds will fund working capital, clinical studies, systems and potential strategic investments.