Biodexa Pharmaceuticals plc reports news on a clinical-stage biopharmaceutical pipeline focused on gastrointestinal cancers, rare diseases and other unmet medical needs. The company’s programs include eRapa for familial adenomatous polyposis and non-muscle invasive bladder cancer, MTX240, a molecular glue candidate for gastrointestinal stromal tumors, and tolimidone for type 1 diabetes.
Recurring developments cover clinical development, regulatory and trial authorizations, manufacturing and access partnerships, licensing, annual results, financing activity, ADR program matters and patient-advocacy initiatives. Biodexa’s American depositary shares trade under BDRX, while company updates may also describe ordinary-share and ADR mechanics for the U.K. issuer.
Biodexa (Nasdaq: BDRX) announced enrolment of the first three European patients into the pivotal Phase 3 Serenta trial of eRapa for familial adenomatous polyposis (FAP) at the University of Bonn, Germany on December 1, 2025. The Serenta trial (NCT06950385) is a double‑blind, placebo‑controlled study of 168 patients randomized 2:1 to evaluate eRapa safety and efficacy.
All sites are identified and onboarding; nine additional European sites across the Netherlands, Spain, Denmark, and Italy are expected to activate in the next 2–3 months. The trial began US enrolment in August 2025 and is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.
Biodexa (Nasdaq: BDRX) activated the University of Bonn as the first European site for the registrational Phase 3 Serenta trial evaluating eRapa in familial adenomatous polyposis (FAP) on November 24, 2025.
The company said this follows approval of its Clinical Trial Application by the European Medicines Agency and cites collaborators Emtora Biosciences, CRO Precision for Medicine, and a $20 million grant from the Cancer Prevention and Research Institute of Texas. The randomized, double-blind, placebo-controlled Serenta trial (NCT06950385) began US enrollment in August 2025. Nine additional European sites across the Netherlands, Spain, Denmark, and Italy are expected to activate in the next 2–3 months. For eligibility and site details visit https://serentatrial.com/.
Biodexa (Nasdaq: BDRX) announced EMA approval of a Clinical Trial Application (CTA) for its pivotal Phase 3 Serenta trial in familial adenomatous polyposis (FAP) on November 3, 2025. The trial will open initially in Denmark, Germany, Netherlands, and Spain with Italy expected to be added later. The U.S. arm enrolled its first patient in mid‑August 2025. Serenta is a randomized, double‑blind, placebo‑controlled Phase 3 registrational study planned to recruit 168 patients randomized 2:1 drug:placebo. Management cites a $7 billion addressable US–European market and expects the first European patient in 4Q 2025.
Biodexa (Nasdaq: BDRX) will host a breakfast symposium titled “FAP mechanisms and Chemoprevention Trial Issues” at the Collaborative Group of the Americas on Inherited Gastrointestinal Cancer (CGA‑IGC) annual meeting in St. Louis, MO, during Oct 9–11, 2025, with the event scheduled for October 11, 2025.
Speakers include guest presenter Dr Patrick Lynch and a panel with Sonia S. Kupfer MD and Paul E. Wise MD. Biodexa highlighted the timing as pivotal for its FAP program while advancing the Phase 3 Serenta trial of eRapa, an oral rapamycin formulation, and noted participation by several Phase 3 clinical investigators.
Biodexa Pharmaceuticals (NASDAQ:BDRX) reported interim results for H1 2025, highlighting significant progress in its clinical pipeline. The company's lead candidate eRapa entered Phase 3 trials for FAP with first patient enrollment in Puerto Rico, while securing Orphan Drug Designation in Europe. The company also initiated a Phase 2a study of tolimidone in Type 1 Diabetes.
Financial highlights include a $35 million Equity Line of Credit with C/M Capital Master Fund LP, and a $3 million grant awarded to collaboration partner Emtora Biosciences. R&D costs decreased to £1.67 million (from £2.19M in 1H24), while cash balance stood at £4.04 million as of June 30, 2025.
[ "Secured $35 million Equity Line of Credit facility", "Collaboration partner received additional $3 million grant, bringing total non-dilutive funding to $20 million", "R&D costs decreased by 24% to £1.67 million", "Successfully advanced eRapa to Phase 3 trials with first patient enrollment", "Obtained European Orphan Drug Designation for eRapa in FAP" ]Biodexa Pharmaceuticals (NASDAQ:BDRX) has announced the enrollment of its first two patients in the pivotal Phase 3 Serenta trial for eRapa, targeting Familial Adenomatous Polyposis (FAP). The trial will be conducted across 30 sites (20 in US, 10 in Europe) and will evaluate 168 patients in a 2:1 drug/placebo randomized study.
The company aims to develop the first non-surgical treatment for FAP, a hereditary condition that typically leads to colorectal cancer if untreated. The program has received $20 million in grant funding from CPRIT and targets a $7.3 billion addressable market. The trial follows promising Phase 2 results and represents a potential breakthrough in FAP treatment, where currently only surgical resection is available.
Biodexa Pharmaceuticals (NASDAQ: BDRX) has implemented its previously announced American Depositary Receipts (ADR) ratio change effective July 31, 2025. The new ratio changes from 1 ADR representing 10,000 ordinary shares to 1 ADR representing 100,000 ordinary shares.
The ratio change functions similarly to a 1-for-10 reverse ADR split, with the exchange occurring automatically through depositary bank JPMorgan Chase Bank. Following the change, the company has 619,523 ADRs outstanding, while the total number of issued ordinary shares remains unchanged at 61,952,308,922.
Biodexa Pharmaceuticals (NASDAQ: BDRX) has announced a significant change in its American Depositary Receipts (ADR) ratio. The company will modify its ADR ratio from 1:10,000 (1 ADR representing 10,000 ordinary shares) to 1:100,000 (1 ADR representing 100,000 ordinary shares), effective July 31, 2025.
ADR holders will be required to exchange their existing ADRs at a ratio of 10:1, with JP Morgan Chase Bank managing the exchange process. This change will effectively function as a 1-for-10 reverse ADR split, though the company's ordinary shares will remain unaffected. The primary goal is to achieve compliance with Nasdaq's minimum bid price requirement of $1.00 per share.
Biodexa Pharmaceuticals (NASDAQ:BDRX) has filed a Clinical Trial Application (CTA) with the European Medicines Agency for its Phase 3 Serenta trial investigating eRapa in Familial Adenomatous Polyposis (FAP). The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy to be added later.
The company has achieved several milestones for its eRapa program, including FDA Fast Track Designation, European Orphan Drug designation, and initiation of its first US clinical site. The program is supported by a $20 million grant from CPRIT. The Serenta trial (NCT06950385) is designed as a randomized, double-blind, placebo-controlled Phase 3 study, with European sites expected to begin enrollment in Q4 2025.
Biodexa Pharmaceuticals (NASDAQ: BDRX), a clinical stage biopharmaceutical company, announced that all resolutions proposed at its Annual General Meeting held on June 26, 2025, were successfully passed by shareholders. The company, which focuses on developing innovative treatments for diseases with unmet medical needs, has made the full text of the passed resolutions available on its corporate website under the investor relations section.