Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAPClears the way to ...

Biodexa Pharmaceuticals (BDRX) announced the results of its Type C meeting with the U.S. Food and Drug Administration, FDA, regarding the ...

"With no approved products for FAP, we were pleased to collaborate with FDA and our US CRO, LumaBridge, to define the regulatory pathway for eRapa in FAP. Agreement on the composite endpoint ...

Biodexa (NASDAQ:BDRX) stock soared 76% in morning trading after the company announced it has received FDA Fast Track designation for its drug eRapa for the treatment of familial adenomatous ...

Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”)(Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of ...

Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of ...

Stephen Stamp, CEO and CFO of Biodexa, commented “The FDA has already granted orphan drug designation for our most advanced program, eRapa in FAP which confers seven years market exclusivity ...

eRapa is a proprietary oral tablet 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 ...

The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted ...

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data ...

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data at ...