Biodexa Pharmaceuticals Advances Phase 3 eRapa Program with FDA Approval

Biodexa Pharmaceuticals ( (BDRX) ) has shared an update.

On March 10, 2025, Biodexa Pharmaceuticals announced a successful Type C meeting with the FDA regarding the Phase 3 program for eRapa in treating familial adenomatous polyposis (FAP). This meeting clears the path for finalizing the Phase 3 protocol and recruiting sites in the U.S., with the study being substantially funded by a $17 million CPRIT grant and an $8.5 million company match. The Phase 3 study will be a double-blind placebo-controlled trial involving 168 patients across approximately 30 clinical sites in the U.S. and Europe. The FDA’s input has enabled Biodexa to define a clear regulatory pathway for eRapa, which is a proprietary oral formulation of rapamycin designed to address issues of bioavailability and toxicity.

More about Biodexa Pharmaceuticals

Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs. The company’s lead development programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancer indications. Biodexa is supported by proprietary drug delivery technologies aimed at improving the bio-delivery and bio-distribution of medicines, with headquarters and R&D facilities in Cardiff, UK.

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