Relmada Therapeutics

RLMD

Market cap $455M

Relmada Therapeutics jumps 42% in a week after reporting encouraging efficacy and safety data from a mid-stage bladder cancer study of NDV-01, simultaneously sharing phase III plans.

CORAL GABLES, Fla., March 12, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced plans to host a conference call and webcast on Thursday, March 19, 2026 at 4:30 PM ET to discuss financial results for the fourth quarter ended December 31, 2025, and recent business progress.

Two small-cap biotech names made serious noise today. Xenon Pharmaceuticals (XENE) is trading at $62.76, up 49.6% today, while Relmada Therapeutics (RLMD) sits at $7.17, also up 61.1% Both moves were absolutely eye-popping, but follow major news that has led investors to re-rate each stock.

CORAL GABLES, Fla., March 09, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in the Leerink Partners Global Healthcare Conference being held in Miami, Florida, from March 8-11, 2026.

CORAL GABLES, Fla., March 09, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, today announced that it has entered into a securities purchase agreement for a private investment in public equity (“PIPE”) financing that is expected to result in gross proceeds of approximately $160.0 million to the Company, before placement agent fees and offering expenses. The PIPE financing included participation from Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, RA Capital Management, Balyasny Asset Management, OrbiMed, Spruce Street Capital, Squadron Capital Management, Columbia Threadneedle Investments, Adage Capital Management, Marshall Wace, Braidwell LP, Great Point Partners, LLC and Eventide Asset Management.

Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time Tolerability profile remains favorable – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations Data reinforces advancement of NDV-01 into Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026 CORAL GABLES, Fla., March 09, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

FDA written feedback supports: - a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase 3 program expected to initiate in 1H 2026 CORAL GABLES, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) -- one of the highest-risk and most treatment-resistant NMIBC populations -- and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies.

Poster highlights 6-month follow-up data from the ongoing Phase 2 trial of NDV-01 in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Relmada plans to advance NDV-01, a sustained release intravesical formulation of gemcitabine/docetaxel (Gem/Doce), into Phase 3 studies in two indications in H1 2026 Company is focused on high-risk NMIBC and intermediate-risk NMIBC, representing about 80% of new NMIBC cases every year, or about 54,000 people in the United States CORAL GABLES, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, today announced that the previously disclosed 6-month follow-up data from the ongoing Phase 2 study of NDV-01, a sustained release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for non-muscle invasive bladder cancer (NMIBC) will be presented in a poster at the Society of Urologic Oncology 26th Annual Meeting (SUO 2025).

Relmada Therapeutics, Inc. ( RLMD ) Q3 2025 Earnings Call November 13, 2025 4:30 PM EST Company Participants Sergio Traversa - CEO & Director Raj Pruthi - Chief Medical Officer of Urology Maged Shenouda - Chief Financial Officer Conference Call Participants Brian Ritchie - Lifesci Advisors, LLC Uy Ear - Mizuho Securities USA LLC, Research Division Presentation Operator Good afternoon, and welcome to Relmada Therapeutics Third Quarter 202 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Relmada website.

Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety