Welcome to our dedicated page for Biodexa Pharmaceuticals plc news (Ticker: BDRX), a resource for investors and traders seeking the latest updates and insights on Biodexa Pharmaceuticals plc stock.
Biodexa Pharmaceuticals (BDRX) is a clinical-stage biopharmaceutical company developing treatments for rare diseases with high unmet needs. Headquartered in Cardiff, United Kingdom, and trading on NASDAQ, the company focuses on advancing drug candidates through clinical trials toward regulatory approval.
News coverage for Biodexa centers on clinical trial milestones, regulatory developments, and funding activities typical of development-stage biotechnology companies. Investors following BDRX typically monitor announcements related to patient enrollment in the Phase 3 Serenta trial for familial adenomatous polyposis (FAP), data readouts from ongoing studies, and FDA interactions regarding the lead candidate eRapa. Clinical trial site activations, institutional review board approvals, and trial enrollment progress represent key indicators of development momentum.
Regulatory news forms another critical category. Updates on FDA designations, guidance meetings, and regulatory pathway discussions directly impact development timelines and commercial prospects. For eRapa, which has received both Fast Track and Orphan Drug designations, regulatory communications carry particular significance as they may affect the approval timeline and market exclusivity provisions.
Financial announcements including equity offerings, warrant exercises, and grant awards provide insight into the company's cash runway and ability to fund clinical programs through key milestones. Like most clinical-stage biotechnology companies, Biodexa requires periodic capital raises to finance drug development. Grant funding from organizations like the Cancer Prevention and Research Institute of Texas (CPRIT) supplements equity financing and reduces shareholder dilution.
Corporate developments such as scientific advisory board appointments, clinical trial collaborations, and partnership agreements also generate news flow. For a small biotechnology company, collaborations with academic medical centers and clinical research organizations prove essential for conducting complex rare disease trials. This news page aggregates these developments in real-time, helping investors track the company's progress toward regulatory submissions and potential commercialization.
Biodexa Pharmaceuticals (NASDAQ:BDRX) is advancing its Phase 3 program for eRapa, an oral tablet formulation of rapamycin, to treat Familial Adenomatous Polyposis (FAP). The company has achieved significant regulatory milestones, including FDA Fast Track status and Orphan Drug designation in both US and Europe.
eRapa demonstrated impressive Phase 2 results with an 89% non-progression rate and 29% median reduction in polyp burden at 12 months. The company has initiated its 'Serenta' trial (NCT06950385) in the US and filed a Clinical Trial Application in Europe, targeting a $7 billion addressable market.
With 30 clinical sites identified across the US and Europe, secured funding including a $20 million grant, and potential first-mover advantage, Biodexa is positioned ahead of competitors Recursion Pharmaceuticals (RXRX) and Tempest Therapeutics (TPST) in the race to develop the first approved therapeutic option for FAP.
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.
Biodexa Pharmaceuticals (NASDAQ:BDRX) has announced the activation of its first clinical study site for the Phase 3 Serenta trial, evaluating eRapa in patients with familial adenomatous polyposis (FAP). The trial (NCT06950385) is designed as a randomized, double-blind, placebo-controlled study and is now actively enrolling participants.
The program has received significant support, including $20 million in grant funding from CPRIT, Fast Track Designation, and a positive Type C Meeting. The company has also launched a dedicated website for patient information at serentatrial.com.
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