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Biodexa Pharmaceuticals plc American Depositary Shs - BDRX STOCK NEWS

Welcome to our dedicated page for Biodexa Pharmaceuticals plc American Depositary Shs news (Ticker: BDRX), a resource for investors and traders seeking the latest updates and insights on Biodexa Pharmaceuticals plc American Depositary Shs stock.

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.
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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.

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Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has closed a $5.0 million registered direct offering and concurrent private placement. The company raised approximately $4.2 million in net proceeds after expenses. The offering included:

1. 5,050,808 American Depositary Shares (ADS) and 278,975 pre-funded warrants at $0.94 per ADS
2. Unregistered Series J and K warrants to purchase up to 5,329,783 ADSs each
3. Amendment of existing warrants' exercise price to $1.00 per share

Funds will be used for development programs, including a $17 million CPRIT grant match and initiating a Phase 3 trial of eRapa for FAP. Ladenburg Thalmann & Co. Inc. acted as the sole placement agent.

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Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has announced a $5.0 million registered direct offering and concurrent private placement. The company will sell 5,050,808 American Depositary Shares and 278,975 pre-funded warrants at $0.94 per share. Additionally, Biodexa will issue unregistered Series J and K warrants in a private placement. The proceeds will fund development programs, including a final match payment for a $17 million CPRIT grant and initiation of a Phase 3 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP). The offering is expected to close around July 22, 2024. Ladenburg Thalmann & Co. Inc. acted as the sole placement agent.

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Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has received approval from Health Canada for a Phase 2a study of tolimidone in Type 1 diabetes (T1D). This Investigator Initiated Trial, to be conducted by the University of Alberta, will measure C-peptide levels and HbA1c after three months compared to baseline, as well as the number of hyperglycemic events. The study will initially involve 12 patients across three dose groups, with potential for expansion. Enrollment of the first patient is expected in the current quarter. This clinical program builds on existing tolimidone data from Pfizer, Melior, and Bukwang.

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Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) has announced positive 12-month data from its Phase 2 clinical trial of eRapa™ for the treatment of Familial Adenomatous Polyposis (FAP), a condition that significantly increases the risk of colorectal cancer. Presented at the 2024 InSIGHT biannual meeting, results indicate a 17% median reduction in polyp burden and a non-progression rate of 75%. Notably, 89% of patients in Cohort 2 (treated daily on alternate weeks) were deemed non-progressors, with a 29% median reduction in polyp burden.

FAP patients currently undergo continuous surveillance and surgeries, often resulting in complete resection of the colon or rectum. Biodexa aims for eRapa to be the first therapeutic alternative, potentially reducing the need for surgical interventions and improving patients' quality of life. The Phase 3 trial, planned to start soon, will involve 140 high-risk FAP patients and be double-blind placebo-controlled. This trial is partially funded by a $17 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

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Biodexa Pharmaceuticals PLC announced positive results from a Phase 1 study of MTX110 in treating Diffuse Midline Glioma (DMG), a pediatric brain cancer. Presented at ISPNO 2024, the study showed a median overall survival of 16.5 months across all patients, compared to 10.0 months in a historical cohort.

The study, conducted by Columbia University Irving Medical Center, involved nine patients receiving two 48-hour infusions of MTX110 via convection enhanced delivery (CED) at escalating doses. The treatment was generally well-tolerated with some adverse events related to the infusion process. The study's primary endpoint was to assess safety and maximum tolerated dose, with secondary endpoints including progression-free survival (PFS) and overall survival (OS).

Results highlight the potential of MTX110 in extending survival in DMG patients, setting a favorable comparison to historical data. Further studies are anticipated to confirm these findings and optimize treatment protocols.

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Biodexa Pharmaceuticals announced positive 12-month results from its Phase 2 clinical trial of eRapa™ for treating Familial Adenomatous Polyposis (FAP). The study revealed a 75% non-progression rate, with a median 17% reduction in overall polyp burden among participants. Cohort 2, comprising patients on a 0.5mg daily dosage every other week, showed the highest efficacy with an 81% non-progression rate and a 29% reduction in polyp burden. These results were presented at the 2024 InSIGHT meeting in Barcelona. The trial, which involved 30 adult participants across seven U.S. centers, was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). A Phase 3 study, supported by a $17 million CPRIT grant, is planned to further evaluate eRapa's potential in reducing the need for surgical intervention in FAP patients.

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Biodexa Pharmaceuticals (NASDAQ: BDRX) announced that all resolutions proposed at its Annual General Meeting on June 13, 2024, were approved by shareholders. This includes key decisions relating to business strategy, governance, and financial operations. Stakeholders can access the full details of these resolutions on the company's website.

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Biodexa Pharmaceuticals announced that they will present 12-month data from a Phase 2 clinical trial of eRapa for Familial Adenomatous Polyposis (FAP) at the InSIGHT 2024 meeting in Barcelona on June 22, 2024.

The trial showed promising results, with significant reductions in polyp burden and high non-progression rates. The six-month data was previously presented at the Digestive Disease Weekly meeting in Washington D.C.

eRapa, an mTOR inhibitor, has received Orphan Designation in the US and plans to seek the same in Europe. The trial demonstrated eRapa to be safe and well-tolerated, with only two Grade 3 Serious Adverse Events reported.

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Biodexa Pharmaceuticals (NASDAQ:BDRX) reported promising results from a Phase 2 trial of eRapa, a drug aimed at treating familial adenomatous polyposis (FAP). This genetic condition, which almost always leads to colorectal cancer if untreated, currently has no non-surgical treatments. The trial included 30 adults and showed a statistically significant 24% reduction in polyp burden after six months, with an 83% non-progression rate. The Cancer Prevention Research Institute of Texas (CPRIT) awarded a $17 million grant for a Phase 3 study, requiring a $8.5 million match, of which Biodexa has secured $7 million. The 12-month results of the Phase 2 trial will be presented at the InSIGHT conference in Barcelona on June 19-22, and a Phase 3 trial is planned for early 2025.

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FAQ

What is the current stock price of Biodexa Pharmaceuticals plc American Depositary Shs (BDRX)?

The current stock price of Biodexa Pharmaceuticals plc American Depositary Shs (BDRX) is $4.52 as of January 10, 2025.

What is the market cap of Biodexa Pharmaceuticals plc American Depositary Shs (BDRX)?

The market cap of Biodexa Pharmaceuticals plc American Depositary Shs (BDRX) is approximately 2.6M.

What is the core business of Biodexa Pharmaceuticals?

Biodexa Pharmaceuticals focuses on improving the bio-delivery and bio-distribution of medicines through innovative drug delivery technologies.

What is eRapa?

eRapa is a phase 3-ready candidate developed for treating Familial Adenomatous Polyposis (FAP) and acquired by Biodexa to expand its oncology pipeline.

What technologies does Biodexa use?

Biodexa employs biocompatible gold nanoparticle (GNP) technology for targeted drug delivery and various proprietary drug delivery systems.

What is MidaForm™ Insulin PharmFilm?

MidaForm™ Insulin PharmFilm is an innovative oral insulin delivery system for diabetic patients, currently in phase II clinical trials.

How is Biodexa funded?

Biodexa secures funding through grants, strategic partnerships, and investments, including a $17 million grant from the Cancer Prevention and Research Institute of Texas for eRapa.

What are the recent achievements of Biodexa?

Recent achievements include the acquisition of eRapa, the advancement of clinical trials, and securing significant non-dilutive funding.

What diseases is Biodexa targeting?

Biodexa targets diseases such as diabetes, various cancers, and specifically, Familial Adenomatous Polyposis (FAP).

What is the significance of Biodexa's GNP technology?

The GNP technology enables precise targeting of therapeutic compounds to specific cells, enhancing the efficacy and reducing side effects.

What are the future plans for Biodexa?

Future plans include progressing with phase 3 trials for eRapa, expanding their development portfolio, and securing further funding and partnerships.

Where can I find more information about Biodexa?

More information can be found on their website or by contacting Stephen Stamp, CEO and CFO, at ir@biodexapharma.com.
Biodexa Pharmaceuticals plc American Depositary Shs

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