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) has appointed Dr Gary A. Shangold as Chief Medical Officer with immediate effect. The appointment comes as Biodexa prepares for a global Phase 3 registrational study in FAP. Dr Shangold brings extensive experience in drug development across multiple therapeutic areas, most recently serving as Chief Medical Officer at Enteris BioPharma.
Dr Shangold's background includes roles as Chief Medical Officer and Executive VP of R&D at Xanodyne Pharmaceuticals, where he successfully secured two NDAs, and President & CEO of NovaDel Pharma. He spent approximately 10 years in clinical and regulatory affairs at Johnson & Johnson's R.W. Johnson Pharmaceutical Research Institute. Currently, he also serves as CMO at 3Daughters and is Founder & CEO of InteguRx Therapeutics. Biodexa has engaged Dr Shangold through his consulting company, Convivotech.
Biodexa Pharmaceuticals (NASDAQ: BDRX), a clinical stage biopharmaceutical company, announced that shareholders approved both resolutions at its General Meeting held on November 22, 2024. The approved resolutions will only reduce the nominal (par) value per ordinary share, with no change to the number of outstanding ordinary shares. The complete text of the resolutions can be found in the Notice of the General Meeting on the company's website.
Biodexa Pharmaceuticals (Nasdaq: BDRX) has successfully regained compliance with Nasdaq's minimum bid price requirement of $1.00 for continued listing. This follows a notice of non-compliance received on August 27, 2024, and a subsequent exception granted by the Nasdaq Hearings Panel on October 14, 2024. The company will remain under a discretionary panel monitor through February 24, 2025, during which it must promptly report any events that could affect its Nasdaq compliance status.
Biodexa Pharmaceuticals (Nasdaq: BDRX) announces a General Meeting scheduled for November 22, 2024, at 13:00 GMT in Cardiff. The Board proposes two key resolutions: 1) subdividing each issued ordinary share of £0.001 into one ordinary share of £0.00005 and 19 C deferred shares of £0.00005, and 2) adopting new articles of association. The purpose is to lower the par value of ordinary shares to enable share issuance above par value. The company confirms that these changes won't affect the number of outstanding ordinary shares or American Depositary Shares.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has successfully appealed its Nasdaq delisting. A Nasdaq Hearings Panel has granted the company an extension until October 31, 2024 to comply with the $1.00 minimum bid price requirement for continued listing. To maintain its listing, Biodexa must demonstrate a closing bid price of at least $1.00 per share for a minimum of 20 consecutive trading days by the given deadline.
Biodexa is described as an acquisition-focused clinical stage biopharmaceutical company developing innovative products for diseases with unmet medical needs. The extension provides the company with additional time to meet Nasdaq's listing requirements and avoid delisting.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has provided an update on its Phase 1 study of MTX110 in recurrent glioblastoma (rGBM). The study, known as MAGIC-G1, involves intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter.
In Cohort A of the study:
- Two patients have deceased with overall survival (OS) of 12 and 13 months
- One patient had progression-free survival (PFS) of 6 months and current OS of 13 months
- One patient has not yet progressed, with current PFS and OS of 12 months
These results compare favorably with typical median PFS of 1.5–6.0 months and median OS of 2.0–9.0 months for rGBM. The data builds on previous promising results from two Phase 1 studies of MTX110 in Diffuse Midline Glioma (DMG), which showed median OS of 16.5 and 26.1 months, compared to a typical median OS of 10.0 months.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) released its unaudited interim results for the six months ended June 30, 2024. Key highlights include:
1. Exclusive worldwide licensing of eRapa™, a Phase 3 ready asset for Familial Adenomatous Polyposis (FAP), with access to a $17 million grant.
2. Positive 6-month and 12-month data for eRapa in FAP, showing high non-progression rates and significant reductions in polyp burden.
3. Promising survival data from MTX110 studies in recurrent Glioblastoma and Diffuse Midline Glioma.
4. Financial updates: R&D costs decreased to £2.19 million, administrative costs reduced to £2.03 million, and cash balance at June 30, 2024 was £5.06 million.
5. Post-period developments include approval for a Phase 2a study of tolimidone in Type 1 diabetes and receipt of $5.0 million from a Registered Direct Offering.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announces a ratio change on its American Depositary Receipts (ADR) effective October 4, 2024. The new ratio will be 1 ADR representing 10,000 ordinary shares, changed from 1 ADR representing 400 ordinary shares.
ADR holders will be required to exchange their existing ADRs, receiving 1 new ADR for every 25 old ADRs. This change will have the same effect as a 1-for-25 reverse ADR split. The company's ordinary shares will not be affected by this change.
The ratio change aims to bring Biodexa's ADR price into compliance with Nasdaq's $1.00 minimum bid price requirement, although the company cannot guarantee its effectiveness in achieving this goal.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has made the final match payment for a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT). This payment enables access to the remaining grant funds, which will be used to finance the upcoming Phase 3 registrational study of eRapa for Familial Adenomatous Polyposis (FAP). FAP is an inherited disease causing precancerous polyps in the GI tract, affecting approximately 100,000 patients in the U.S. and Europe. A previous 12-month Phase 2 trial of eRapa showed promising results, with a 17% median decrease in overall polyp burden and a 75% non-progression rate. The Phase 3 trial is expected to begin enrollment in early 2025.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) received a delisting determination from Nasdaq on August 27, 2024, due to its stock closing below $1.00 for 30 consecutive business days. This violates Nasdaq Listing Rule 5550(a)(2). The company is not eligible for the usual 180-day compliance period because it has effected reverse stock splits with a cumulative ratio of 250:1 or more over the past two years.
Biodexa plans to appeal the decision by requesting a hearing before the Nasdaq Hearings Panel. This request will automatically stay any suspension or delisting action pending the hearing and any additional extension period granted by the Panel. The company remains focused on developing innovative products for diseases with unmet medical needs.