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 ...

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 ...

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 (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 ...

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 ...

March 10, 2025 Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP Clears the way to finalize Phase 3 protocol and recruit sites for U ...

Biodexa Pharmaceuticals has announced that the US FDA has granted Fast Track designation for its drug eRapa, an encapsulated form of rapamycin, which is being developed for familial adenomatous ...

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 ...

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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 in ...