Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications
Relmada Therapeutics, Inc. (RLMD)
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Source: GlobeNewswire
FDA written feedback supports: - a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase 3 program expected to initiate in 1H 2026 CORAL GABLES, Fla., Jan. 12, 2026 (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 disorders, today announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) -- one of the highest-risk and most treatment-resistant NMIBC populations -- and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies. In its
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News
- Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications [Yahoo! Finance]Yahoo! Finance
- Relmada Therapeutics (NASDAQ:RLMD) was upgraded by analysts at Jefferies Financial Group Inc. to a "strong-buy" rating.MarketBeat
- Relmada Therapeutics (NASDAQ:RLMD) is now covered by analysts at Jefferies Financial Group Inc.. They set a "buy" rating on the stock.MarketBeat
- 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
RLMD
Earnings
- 11/13/25 - Miss
RLMD
Sec Filings
- 12/16/25 - Form 4
- 12/16/25 - Form 4
- 12/16/25 - Form 4
- RLMD's page on the SEC website