Biodexa Hits 100-Patient Milestone in Phase 3 FAP Trial, Sees Faster Path to Data
BDRX is trading near its 52-week low of $0.378 (13% above the low) on light trading volume (0.1× avg).
Summary
Biodexa has enrolled 100 patients in its registrational Phase 3 Serenta trial of eRapa for Familial Adenomatous Polyposis (FAP), a milestone that triggers a materially faster timeline than originally planned. Management now expects the pre-specified futility analysis early next year and database lock around the end of next year, both significantly sooner than anticipated. This is the first disclosure of the enrollment count and the accelerated event-driven timeline. The company has a $20 million CPRIT grant supporting the program, but its cash position is tight — £3.23 million at June 30 with a going concern warning. The upcoming 1-for-8 reverse split on October 26 is designed to address Nasdaq listing requirements. Faster data readouts could be a meaningful catalyst for a micro-cap stock trading at $0.43.
Updates
· SEC 6-K — Biodexa filed a 6-K with the press release announcing 100 patients enrolled in the Serenta Phase 3 trial and updated timing: futility analysis could occur early next year and database lock around the end of next year.
At the time of this announcement, BDRX was trading at $0.43 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $394.3K. The 52-week trading range was $0.38 to $52.05. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.