CORAL GABLES, Fla., March 9, 2026, 09:04 EDT
Relmada Therapeutics plans to pull in roughly $160 million through a private placement, the company said Monday, after releasing year-long mid-stage trial data backing a move into late-stage development for NDV-01, its investigational bladder cancer drug. The round, oversubscribed and set at $4.75 per share, is expected to close around March 11.
These back-to-back updates carry weight as Relmada gears up for pricier, more challenging approval-driven trials. Back in January, Relmada said it had received U.S. Food and Drug Administration feedback supporting two routes for NDV-01: a single-arm trial targeting second-line, BCG-unresponsive high-risk cases, and a randomized study for intermediate-risk patients following tumor-removal surgery.
NDV-01 is aimed at non-muscle invasive bladder cancer, meaning the tumors haven’t moved beyond the bladder lining. Relmada’s focus includes patients whose cancer has stopped responding to Bacillus Calmette-Guerin, or BCG, a widely used bladder treatment. For these patients, options that avoid bladder removal are still few, despite the arrival of some new therapies.
Relmada reported that NDV-01 showed a 76% complete response rate after 12 months—no detectable cancer. Among patients unresponsive to BCG, the rate was 80%. According to the company, none of the participants progressed to muscle-invasive disease or needed bladder removal surgery, and there were no treatment-related side effects of Grade 3 or higher.
But it’s still early days for the readout. The study in question is open-label, single-arm, and happening at just one center. That 12-month number? Nineteen complete responses from 25 patients who made it to the one-year mark, out of 48 dosed so far. The financing deal, meanwhile, hasn’t closed yet—it’s still subject to the usual conditions.
Relmada is going for a PIPE deal—selling shares straight to a hand-picked group of investors. The company’s offering: roughly 29.5 million shares of common stock, plus pre-funded warrants that cover another 4.2 million shares. Relmada said the cash will support working capital and push its product candidates forward.
Raj Pruthi, Relmada’s chief medical officer for oncology, pointed to “potential durability” in the response profile for NDV-01. For Max Kates—a urologic oncologist at Johns Hopkins and clinical adviser to Relmada—the drug’s “less than 5-minute administration” stands out as a possible advantage for broader adoption in community settings. Relmada Therapeutics, Inc.
The field is getting crowded. In September, Johnson & Johnson secured U.S. approval for Inlexzo in high-risk, BCG-unresponsive non-muscle invasive bladder cancer. UroGen Pharma picked up a nod in June for Zusduri in low-grade tumors. CG Oncology, meanwhile, is pushing ahead with late-stage trials targeting both high-risk BCG-unresponsive and intermediate-risk groups.
Relmada pivoted to NDV-01 following its decision to halt late-stage depression drug trials in December 2024. The company had secured $100 million back in November, projecting at the time that the proceeds would keep operations funded through 2028.
Investors such as Venrock Healthcare Capital Partners, RA Capital Management, and OrbiMed backed Monday’s financing. Relmada is eyeing a mid-2026 kickoff for its Phase 3 RESCUE program. The company said it’s on track to report initial three-month results from the second-line BCG-unresponsive study before year-end.
