subslover
2週前
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
February 10, 2025
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Underscores unmet need for a therapeutic alternative with the potential to delay or prevent surgical removal of the colon and/or rectum
Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced today that the US Food and Drug Administration (“FDA”) has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The designation was requested based on the potential for eRapa to address an unmet medical need for FAP, a condition which left untreated universally leads to colorectal cancer. Today, the only treatment option is surgical resection of the colon and/or rectum. Data from the Phase 2 study of eRapa in FAP showed eRapa to be safe and well-tolerated with a median 17% reduction in total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. Patients in cohort 2 experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The dosing given to cohort 2 – daily every other week -- is the preferred dosage regimen for the upcoming registrational Phase 3 study.
eRapa in FAP
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 universally leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported prevalence of one in 5,000 to 10,000 in the US1 and one in 11,300 to 37,600 in Europe2. Biodexa has received US FDA Orphan Drug designation for eRapa in FAP and plans to seek a
subslover
4月前
October 15, 2024
Biodexa Announces Successful Appeal of Nasdaq Delisting
Biodexa Pharmaceuticals PLC. (the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced today that a Nasdaq Hearings Panel (the “Panel”) has granted the Company’s request for an extension of time to demonstrate compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq Stock Market LLC (“Nasdaq”) set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). As a condition of the Panel’s decision, the Company is required to demonstrate compliance with the Minimum Bid Price Requirement by evidencing a closing bid price of at least $1.00 per share for a minimum of 20 consecutive trading days by October 31, 2024.
Invest-in-America
8月前
BDRX: If you did NOT 'toss-the-farm' at this, well, YES ya might see what transpires in the Post-M here. It appears to be attempting somewhat of a (feeble) 'comeback' the last several minutes. Myself, I simply believe that the RECTUM-stuff this Firm deals with just did NOT resonate well with Wall Street. So, pun intended, WE got it up the ASS!!!!