BioCryst withdraws BCX5191 lND following discussion with FDA
US biotech firm BioCryst Pharmaceuticals (Nasdaq: BCRX) says it is withdrawing its Investigational New Drug (IND) application for the antiviral nucleoside, BCX5191, following a discussion with the US Food and Drug Administration where safety issues were raised. Shares of BioCryst fell 30% following the announcement last week.
The news comes shortly after BioCryst announced an agreement to acquire privately-held Presidio Pharmaceutical, aiming to create a major force in the hepatitis setting, with the combined entity owning a unique portfolio of three oral, pan-genotypic antivirals that are suitable either for development in combination with each other or in combination with other direct acting antivirals (DAAs) to treat patients with HCV infection. (The Pharma Letter October 22).
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