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. 1
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. 2
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. 2
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. 3
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. 3
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. 4
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. 3
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. 5
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. 6
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. 4
