Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US - European Market Put at $7 Billion
Biodexa Pharmaceuticals plc - American Depositary Shares (BDRX)
Company Research
Source: GlobeNewswire
November 3, 2025 Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US - European Market Put at $7 Billion Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced the approval of a Clinical Trial Application (CTA) by the European Medicines Agency (EMA) of its pivotal Phase 3 Serenta trial in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only current treatment option is sequential resection of much of the gastrointestinal tract. A CTA is the formal regulatory submission required to obtain approval to begin a clinical trial in Europe and is similar to the Investigational New Drug (IND) application process in the Unit
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- Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAPGlobeNewswire
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BDRX
Sec Filings
- 11/24/25 - Form 424B3
- 11/24/25 - Form 424B3
- 11/24/25 - Form EFFECT
- BDRX's page on the SEC website