The initial announcement detailed interim findings from the company’s Phase 2 study evaluating NDV-01 for treating high-risk non-muscle invasive bladder cancer (NMIBC). Data revealed a complete response rate of 76% at 12 months, accompanied by a well-tolerated safety profile. Notably, this response rate was also achieved among BCG-unresponsive patients.
According to Raj S. Pruthi, MD, who serves as Chief Medical Officer of Oncology at Relmada, the findings provide “meaningful clinical validation” for the development program.
Relmada Therapeutics, Inc., RLMD
Management indicated their intention to progress NDV-01 into a pivotal Phase 3 study dubbed the RESCUE program, which will pursue dual registration pathways: one targeting BCG-unresponsive cases and another focusing on adjuvant intermediate-risk patients. The Phase 3 trial initiation is anticipated around mid-2026.
Concurrent with the clinical update, Relmada disclosed the successful pricing of an oversubscribed $160 million private investment in public equity (PIPE) transaction.
The financing arrangement includes the sale of 29,474,569 common shares at $4.75 apiece, alongside pre-funded warrants covering an additional 4,210,527 shares at $4.749 with a nominal exercise price of $0.001.
Jefferies, Leerink Partners, Piper Sandler, and Mizuho are serving as placement agents for the transaction. The financing is projected to close on March 11, 2026, pending customary closing conditions.
Funds raised will be allocated toward general working capital requirements and the advancement of the company’s research and development initiatives.
The agreement provides investors with resale registration rights. Relmada has undertaken to maintain timely SEC compliance, with provisions for liquidated damages amounting to 1.0% for each 30-day delay period if filing deadlines are not met, though these damages are subject to certain limitations.
RLMD shares advanced 31.01% in pre-market activity on Monday. The stock had recorded a modest uptick during Friday’s session.
For the year-to-date period, shares remain down 7.87%. Looking back over the trailing 12 months, however, the stock has delivered extraordinary gains of 1,536%.
Trading activity exploded following the news. Volume exceeded 7.9 million shares on Monday, dramatically surpassing the three-month daily average of approximately 570,000 shares.
This volume spike — representing more than 13 times the typical daily turnover — underscores the significant investor interest generated by both announcements.
Among Wall Street analysts covering the stock, RLMD currently holds a Strong Buy consensus rating, supported by four Buy recommendations published within the last three months.
The mean price target stands at $10.25, suggesting potential upside of approximately 130% from prevailing price levels.
The post Relmada Therapeutics (RLMD) Stock Jumps 31% on Breakthrough Bladder Cancer Data appeared first on Blockonomi.
