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Biodexa Pharmaceuticals Plc (NASDAQ: BDRX) is a pioneering company in the field of drug delivery technology, dedicated to enhancing the bio-delivery and bio-distribution of medicines. The firm integrates approved and developed medications with its proprietary drug delivery technologies to create impactful products that can significantly improve patients' lives.
One of the core focuses of Biodexa is its innovative biocompatible gold nanoparticles (GNPs) technology, which is designed to target specific cells and tissues, offering precision in treatment. The company's therapeutic pipeline includes promising candidates for diabetes and various cancers. Through its strategic joint venture, MidaSol Therapeutics LP, with MonoSol Rx LLC, Biodexa has been developing MidaForm™ Insulin PharmFilm, an oral insulin delivery system currently in phase II clinical trials.
Recently, Biodexa has made significant strides with its acquisition of eRapa™, a phase 3-ready candidate aimed at treating Familial Adenomatous Polyposis (FAP). This acquisition not only expands Biodexa's portfolio but also brings in a substantial $17 million grant from the Cancer Prevention and Research Institute of Texas to support the phase 3 program. The company aims to begin registrational phase 3 clinical trials in the first quarter of next year, with eRapa showing promising phase 2 results in reducing polyp burden in FAP patients.
Biodexa's robust development pipeline includes three pharmaceutical compounds covering seven indications, six of which are in clinical stages. The company's commitment to innovation is further exemplified by multiple Orphan Drug Designations from the FDA for its products. With an eye on the future, Biodexa continues to leverage strategic partnerships, cutting-edge technology, and non-dilutive funding to deliver transformative therapeutic solutions to unmet medical needs.
For more information, please visit the Biodexa Pharmaceuticals website or contact Stephen Stamp, CEO, and CFO at ir@biodexapharma.com.
Latest News:
- June 3, 2024: Biodexa reports promising phase 2 results for eRapa in treating FAP.
- May 22, 2024: Biodexa announces the acquisition of worldwide rights to eRapa.
- May 21, 2024: Updates on phase 3 trials and financial conditions.
- April 30, 2024: Registrational phase 3 clinical trials for eRapa are expected to start in the first quarter of next year.
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.
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.