Relmada Therapeutics stock jumps 25% on bladder cancer data

2026-03-09 19:17:01

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Investing.com – Relmada Therapeutics, Inc. (NASDAQ: RLMD) stock rose 25% on Monday after the company announced mid-term 12-month data from its Phase 2 clinical trial evaluating NDV-01 for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC).

The trial showed a 12-month complete response (CR) rate of 76%, with 95% of patients achieving complete remission at any time point. Among BCG non-responders, the 12-month complete response rate reached 80%, with 94% of patients achieving complete remission at any time point.

The company reported that no patients progressed to muscle-invasive disease or required radical cystectomy. In terms of safety, there were no treatment-related adverse events of grade 3 or higher, and no discontinuations due to treatment-related reasons.

Of the 48 patients who received at least one dose of treatment, 30 (63%) experienced treatment-related adverse events. The most common was urinary difficulty, occurring in 54% of patients, while 8% had asymptomatic positive urine cultures, and 8% experienced hematuria.

Relmada plans to advance NDV-01 to a Phase 3 RESCUE registration trial by mid-2026, targeting two pathways: second-line BCG non-responders with NMIBC and adjuvant treatment for intermediate-risk NMIBC. The company estimates that in the U.S., approximately 75,000 patients are affected annually in the intermediate-risk market, with about 5,000 patients affected annually by BCG non-responders with carcinoma in situ.

The company also announced a private equity financing expected to raise approximately $160 million in total proceeds. Relmada will sell 29,474,569 common shares at $4.75 per share and sell pre-emptive warrants to purchase 4,210,527 shares at $4.749 per warrant. The financing is expected to close around March 11, 2026.

Jefferies, Leerink Partners, Piper Sandler, and Mizuho serve as placement agents for this financing.

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