Biodexa Announces Clinical Trial Application Approval Of Phase 3 Serenta Trial, Stock Down

(RTTNews) - Biodexa Plc (BDRX), Monday announced the approval of a Clinical Trial Application by the European Medicines Agency of its pivotal Phase 3 Serenta trial in patients with familial adenomatous polyposis.

The CTA permits the Serenta trial to proceed in Europe, initially covering clinical sites in Denmark, Germany, Netherlands and Spain with Italy expected to be added in due course.

The company expects to enroll first European patient in the fourth quarter of 2025.

This approval marks an important milestone for the company's Phase 3 program of eRapa, a proprietary oral capsule formulation of rapamycin, also known as sirolimus.

Currently, Biodexa's stock is falling 12.89 percent, to $5.54 on the Nasdaq.