Relmada Details Mid-2026 Phase 3 Start for NDV-01, Reports Q4 Results
Summary
Relmada Therapeutics reported its fourth quarter and full year 2025 financial results and provided a business update. While the update reiterated previously announced positive 12-month Phase 2 data for NDV-01, successful $160 million PIPE financing, and FDA alignment on two registrational pathways, the report also provided new, specific upcoming milestones. These include anticipated mid-2026 IND clearance and Phase 3 RESCUE program initiation for NDV-01, mid-2026 Phase 2 initiation for Sepranolone, and initial 3-month NDV-01 data expected by year-end 2026. For a clinical-stage biotechnology company, these concrete timelines for advancing lead programs are material and provide important clarity on the company's development path. Investors will now watch for the successful execution and initiation of these critical clinical trials.
At the time of this announcement, RLMD was trading at $5.86 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $458.3M. The 52-week trading range was $0.24 to $7.51. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.