Relmada Announces FDA Feedback Supporting 2 Separate Acceptable Registrational Study Paths for NDV-01 in Non-muscle Invasive Bladder Cancer
Relmada Therapeutics, Inc. (RLMD)
NASDAQ:AMEX Investor Relations:
ir.relmada.com
Company Research
Source: GlobeNewswire
Announces NDV-01 9-Month Follow-up Safety and Efficacy Data in NMIBC FDA feedback supports 2 potential registrational trials – 1) a registrational trial in 2nd line refractory BCG-unresponsive NMIBC, and 2) a randomized controlled trial in intermediate-risk NMIBC. FDA Feedback also confirms no additional non-clinical studies are required. 9-month follow-up for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer, with good overall safety CORAL GABLES, Fla., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, today announced the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. The Company will be requesting f
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News
- Relmada Therapeutics Announces Presentation of NDV-01 Phase 2 Data at the Society for Urologic OncologyGlobeNewswire
- Relmada Therapeutics (NASDAQ:RLMD) was upgraded by analysts at Mizuho from a "neutral" rating to an "outperform" rating. They now have a $10.00 price target on the stock.MarketBeat
- Relmada Therapeutics GAAP EPS of -$0.30 [Seeking Alpha]Seeking Alpha
- Relmada Therapeutics to Report Third Quarter 2025 Financial Results on Thursday, November 13, 2025GlobeNewswire
- Relmada Therapeutics Announces Pricing of $100 Million Underwritten Offering of Common Stock and Pre-Funded WarrantsGlobeNewswire
RLMD
Earnings
- 11/13/25 - Miss
RLMD
Sec Filings
- 11/14/25 - Form SCHEDULE
- 11/6/25 - Form 4
- 11/6/25 - Form 4
- RLMD's page on the SEC website