Relmada Therapeutics received written minutes from a Type B pre‑IND meeting with the U.S. Food and Drug Administration confirming that no additional non‑clinical studies are required for its NDV‑01 program. The FDA feedback supports two potential registrational trial designs: a single‑arm study in second‑line refractory BCG‑unresponsive non‑muscle invasive bladder cancer and a randomized controlled trial in intermediate‑risk NMIBC.
In its Phase 2 study of 36 patients, NDV‑01 achieved an overall response rate of 92% at any time and a complete response rate of 85% at 9 months. In the BCG‑unresponsive subpopulation, the complete response rate was 88% at 9 months. Sixty‑one percent of patients experienced a treatment‑related adverse event, with no Grade ≥ 3 events reported.
Relmada completed a $100 million underwritten offering of common stock and pre‑funded warrants to support working capital and clinical development. As of September 30 2025, the company had approximately $13.9 million in cash, cash equivalents, and short‑term investments. The company has no revenue and continues to incur significant cash burn, prompting a strategic shift toward exploring product acquisitions after discontinuing Phase 3 studies for REL‑1017 in major depressive disorders.
The company plans to initiate Phase 3 programs in the first half of 2026 and will seek additional FDA meetings to refine the trial designs. The FDA alignment is a key milestone that could position NDV‑01 as a leading bladder‑sparing therapy.
Non‑muscle invasive bladder cancer accounts for 75% of newly diagnosed bladder cancers, with high recurrence and progression rates. BCG therapy fails in nearly 40% of high‑risk patients, creating an unmet need for alternative treatments. NDV‑01, a sustained‑release intravesical formulation of gemcitabine and docetaxel, offers a convenient, in‑office administration that could address this gap and compete with emerging therapies such as TAR‑200, UGN‑102, nadofaragene firadenovec, and CG0070.
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