Biodexa Launches Global Early Access Program for eRapa for FAP Patients Through Strategic Partnership with Tanner Pharma Group
Rhea-AI Summary
Biodexa (Nasdaq: BDRX) has launched a global Early Access Program for its investigational medicine eRapa to treat Familial Adenomatous Polyposis (FAP) patients via a strategic partnership with Tanner Pharma Group.
The program enables clinicians worldwide to prescribe eRapa outside clinical trials, subject to local laws and funding, and Biodexa will collect Real World Data to better understand FAP patient experiences.
Positive
- Global Early Access Program enables prescribing outside trials
- Strategic partnership with Tanner Pharma Group expands distribution
- Real World Data generation to inform FAP patient understanding
Negative
- Investigational status — eRapa is not an approved therapy
- Program availability is subject to local legislation and funding
News Market Reaction – BDRX
On the day this news was published, BDRX declined 2.37%, reflecting a moderate negative market reaction. Argus tracked a peak move of +4.0% during that session. Argus tracked a trough of -11.1% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $14K from the company's valuation, bringing the market cap to $587,654 at that time.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
BDRX was up 2.11% while momentum peers were mixed: TOVX up 26.07% and DRMA down 10.96%, indicating a stock-specific reaction rather than a coordinated biotech move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 18 | ADR ratio change | Negative | -10.9% | Reverse ADR split to help address Nasdaq minimum bid requirement. |
| Mar 09 | FAP advocacy support | Positive | +4.9% | Funding first U.S. FAP advocacy group and highlighting Phase 3 eRapa program. |
| Feb 19 | Drug license deal | Positive | +3.2% | Licensing MTX240, a Phase 1–ready molecular glue for GIST from Otsuka. |
| Feb 04 | Exclusive license MTX240 | Positive | -11.0% | Exclusive license of Otsuka’s OPB-171775 (MTX240) for GI oncology pipeline. |
| Jan 05 | CFO board appointment | Neutral | +2.0% | Promotion of Fiona Sharp to CFO, Company Secretary and Board director. |
BDRX has generally risen on positive pipeline and advocacy news but has shown at least one sharp selloff following a positive licensing update.
Over the last few months, Biodexa reported several strategic steps across its GI-oncology portfolio. Licensing deals for Phase 1–ready molecular glue MTX240 for GIST and advancement of eRapa, including its Phase 3 status and FDA Fast Track, highlighted pipeline building. Corporate actions included an ADR ratio change aimed at Nasdaq bid compliance and a CFO appointment. Recent FAP-focused advocacy support on Mar 9, 2026 drew a positive price reaction, providing context for today’s Early Access partnership around eRapa.
Market Pulse Summary
This announcement describes a strategic partnership to launch a global Early Access Program for eRapa in Familial Adenomatous Polyposis, giving clinicians a way to request the investigational therapy outside traditional trials. It reinforces Biodexa’s FAP focus alongside its Phase 3 eRapa program and recent advocacy initiatives. Investors may watch how much Real World Data is generated, clinician uptake, and how this complements the existing registrational trial and broader GI-oncology pipeline developments.
Key Terms
early access program regulatory
named patient prescribing regulatory
investigational medicine medical
real world data technical
familial adenomatous polyposis medical
AI-generated analysis. Not financial advice.
March 23, 2026
Biodexa Launches Global Early Access Program for eRapa for FAP Patients
Through Strategic Partnership with Tanner Pharma Group
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has entered into a strategic partnership with Tanner Pharma Group to make eRapa available for Familial Adenomatous Polyposis (FAP) patients via an Early Access Program and Named Patient prescribing. This initiative gives clinicians who treat FAP patients the opportunity to prescribe this investigational medicine outside of a clinical trial for the first time.
The program will be open to clinicians globally, for appropriate patients and subject to local legislation and the availability of government or private funding. As part of this initiative and underscoring its long-term commitment to the therapy area, Biodexa will also be generating Real World Data to further expand the understanding of the issues faced by FAP patients in their daily lives.
Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said “We are committed to improving the lives of patients with FAP and are therefore proud to be able to make eRapa available to more clinicians treating FAP patients for whom there are no currently approved therapeutic options, only life-altering surgery.”
About Familial Adenomatous Polyposis
FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.
About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 patients randomized 2:1, drug: placebo. The Phase 3 program is supported by a
About Tanner Pharma Group
Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte, USA. The company has developed a portfolio of service offerings focused on improving the global access to medicines. Tanner supports manufacturers by providing ethical, controlled and compliant access to their innovative medicines in countries where they are not commercially accessible. For more information, visit www.tannerpharma.com.
The Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded
About Biodexa Pharmaceuticals PLC
The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes.
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis.
MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signalling.
Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.
Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.
For more company information, please contact:
Stephen Stamp, CEO
Fiona Sharp, CFO
Tel: +44 (0)29 20480 180
www.biodexapharma.com
For program information, contact erapa@tannerpharma.com
Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict,
that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.
Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
FAQ
What is Biodexa announcing about eRapa for FAP patients (BDRX) on March 23, 2026?
How can clinicians access eRapa for FAP patients under Biodexa's (BDRX) program?
Will Biodexa collect data from patients receiving eRapa under the Early Access Program (BDRX)?
Does the eRapa Early Access Program mean regulatory approval for FAP (BDRX)?
What limits might affect uptake of Biodexa's (BDRX) eRapa Early Access Program worldwide?
