Welcome to our dedicated page for Biodexa Pharmaceuticals news (Ticker: BDRX), a resource for investors and traders seeking the latest updates and insights on Biodexa Pharmaceuticals stock.
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 Pharmaceuticals (Nasdaq: BDRX) announced an initial financial grant supporting the launch of Life's a Polyp Foundation, the first U.S. patient advocacy group focused exclusively on Familial Adenomatous Polyposis (FAP).
Biodexa highlighted its lead program eRapa, an encapsulated rapamycin in the registrational Phase 3 Serenta trial with >20% enrollment and FDA Fast Track designation, and said the grant aims to boost patient resources, community support, and awareness for FAP patients and families.
Biodexa (Nasdaq: BDRX) closed an exclusive license with Otsuka for OPB-171775, a Phase 1–ready molecular glue intended for treatment of gastrointestinal stromal tumours (GIST). Biodexa will develop the asset as MTX240, citing activity in TKI‑resistant PDX models and potential use in additional indications. The program aligns with Biodexa's GI/oncology pipeline alongside its Phase 3 eRapa program in Familial Adenomatous Polyposis.
Biodexa Pharmaceuticals (Nasdaq: BDRX) announced on January 5, 2026 the promotion of Fiona Sharp to Chief Financial Officer and Company Secretary and her election to the Board of Directors, effective immediately.
Ms Sharp joined Biodexa as Group Financial Controller in December 2019 and has assumed many CFO responsibilities during her tenure. Her prior roles include Assistant Director of Finance at Hywel Dda University Health Board (over 10,000 staff; budget ~£800 million) and senior finance roles at Chime Communications Group (revenues ~£570 million) from 1999 until early 2018. Stephen Stamp will relinquish his CFO and Company Secretary roles but will remain as Chief Executive Officer.
Biodexa Pharmaceuticals (Nasdaq: BDRX) priced a best efforts public offering expected to raise aggregate gross proceeds of approximately $10.0 million before fees and expenses. The offering consists of (i) 157,000 ADS Units (one ADS representing 100,000 ordinary shares plus two Series L warrants) at a combined price of $3.28 per ADS Unit, and (ii) 2,891,781 pre-funded units at $3.2799 each. Each Series L Warrant is immediately exercisable at $3.28 and expires five years after issuance. The company intends to use net proceeds for development programs, working capital and general corporate purposes. The offering is expected to close on December 19, 2025, subject to customary closing conditions; Maxim Group is sole placement agent and the SEC declared the registration statement effective on December 17, 2025.
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.