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. develops clinical-stage therapies for oncology and central nervous system disorders. Company news centers on NDV-01, an intravesical sustained-release gemcitabine-docetaxel therapy being evaluated for non-muscle invasive bladder cancer, including clinical data, FDA feedback on registrational study design, and presentations at medical conferences.
Recurring updates also cover quarterly and annual financial results, business progress, healthcare conference participation, and financing activity tied to the company’s clinical development plans.
Relmada Therapeutics (Nasdaq: RLMD) will participate in the Jefferies Global Healthcare Conference in New York from June 2-4, 2026. CEO Sergio Traversa and CFO Maged Shenouda will join a fireside chat on Thursday, June 4, 2026, at 12:50 PM ET.
A live webcast and 90-day replay will be available via the Relmada investor relations website, and management will hold one-on-one investor meetings scheduled through Jefferies.
Relmada Therapeutics (Nasdaq: RLMD) reported Q1 2026 results and a business update focused on NDV-01 in high-risk NMIBC.
NDV-01 12‑month Phase 2 data showed CR rates of 95% (any time) and 76% at 12 months; in BCG‑unresponsive patients, CR rates were 94% and 80%, with no progression to muscle‑invasive disease or radical cystectomies.
Relmada plans to file an NDV-01 IND and start the Phase 3 RESCUE program in mid‑2026, filed a provisional NDV‑01 patent expected to run to April 2047 if issued, and will present data at AUA2026. Q1 R&D was $8.1M, G&A $11.4M, net loss $19.1M, and cash was $234.0M, expected to fund operations through 2029.
Relmada Therapeutics (Nasdaq: RLMD) will report first quarter 2026 financial results and host a conference call and webcast on Tuesday, May 12, 2026 at 4:30 PM ET. The company will discuss results for the quarter ended March 31, 2026 and provide updates on recent business and clinical progress.
Participant dial-in numbers and a webcast link are provided; a replay will be available in the Investors section of the Relmada website.
Relmada Therapeutics (Nasdaq: RLMD) will present two abstracts on NDV-01 at AUA2026 in Washington D.C., May 15-18, 2026. A 12-month Phase 2 update in high-risk NMIBC will be presented May 15, and a Phase 3 overview (RESCUE program) will appear in a Trials-in-Progress session May 17.
The company said the Phase 3 RESCUE registrational program remains on track to be initiated mid-2026. Exact presentation times and locations may change.
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.