Relmada Therapeutics Inc Stock Price, News & Analysis

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.

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.