Biodexa Pharmaceuticals plc Stock Price, News & Analysis

Biodexa Pharmaceuticals (NASDAQ:BDRX) has received FDA Fast Track status for eRapa, its drug treating familial adenomatous polyposis (FAP), following positive Phase 2 results and Orphan Drug designation. The Phase 2 trial showed promising results with a 17% median decrease in overall polyp burden and 75% non-progression rate. Notably, cohort 2 demonstrated an 89% non-progression rate and 29% median reduction in polyp burden at 12 months.

FAP is an inherited condition affecting 1 in 5,000-10,000 people in the U.S. and 1 in 11,300-37,600 in Europe, leading to a nearly 100% lifetime risk of colorectal cancer. Currently, there are no approved therapeutic options, with surgery being the standard treatment. The upcoming Phase 3 study will be double-blind placebo-controlled, recruiting approximately 168 high-risk FAP patients.

Biodexa Pharmaceuticals (Nasdaq: BDRX) has received FDA Fast Track designation for eRapa, their proprietary encapsulated rapamycin treatment for familial adenomatous polyposis (FAP). This designation aims to expedite development and review of drugs addressing serious unmet medical needs.

The Phase 2 study of eRapa demonstrated promising results with a median 17% reduction in total polyp burden at 12 months and a 75% non-progression rate. Notably, cohort 2 showed even better outcomes with an 89% non-progression rate and 29% median reduction in polyp burden using an alternate-week dosing regimen, which will be used in the upcoming Phase 3 study.

FAP, affecting 1 in 5,000-10,000 people in the US and 1 in 11,300-37,600 in Europe, currently has no approved therapeutic options besides surgical removal of the colon/rectum. eRapa has also received FDA Orphan Drug designation for FAP treatment.

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) is advancing its transformation from a drug delivery innovator to a therapeutics company, focusing on diabetes and cancer treatments. The company's strategy involves repurposing proven molecules for new indications. Their key product eRapa for familial adenomatous polyposis (FAP) showed promising Phase 2 results with a 29% median decrease in polyp burden and 89% non-progression rate. The Phase 3 study is largely funded through a $25.5 million grant and matching funds. Additionally, Biodexa is developing MTX110 for glioblastoma and tolimidone for Type 1 diabetes, with several clinical milestones expected in the coming months.

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 (NASDAQ:BDRX) has released positive patient updates from its ongoing MAGIC-1 study of MTX110 in recurrent glioblastoma (rGBM). The study is evaluating the feasibility, safety, and efficacy of treating rGBM patients with MTX110, a proprietary combination of water-soluble panobinostat and a convection-enhanced delivery system.

Key findings include:

• Patients #1 and #2 in Cohort A achieved overall survival (OS) of 12 and 13 months, respectively
• Patient #3 has achieved 13 months OS to date, with six months progression-free survival (PFS)
• Patient #4 has not progressed and achieved 12 months PFS and 12 months OS to date

These results are promising, considering the median survival post-recurrence for rGBM is typically 6.5 months. The data builds on earlier trial results with MTX110 in Diffuse Midline Glioma (DMG), suggesting potential for a shift in standard of care for aggressive brain cancers.

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.