Market Overview

BioCryst Announces Withdrawal of BCX5191 Investigational New Drug Application Following Discussion With FDA

BioCryst
Pharmaceuticals (NASDAQ: BCRX) today announced the withdrawal
of its Investigational New Drug application (IND) for the antiviral
nucleoside, BCX5191,
following a discussion with the U.S. Food and Drug Administration (FDA).

The FDA indicated concerns regarding the preclinical toxicity profile of
BCX5191 at exposure levels that they believe are likely to be necessary
to reduce viral load in patients infected with the hepatitis C virus
(HCV). Patient safety remains BioCryst's highest priority. BioCryst
continues to believe that BCX5191 may be distinct from other Nucs in
exhibiting antiviral potency in man at significantly lower doses than
other Nucs in development based on preclinical results, and will
therefore

See full press release

Posted-In: Earnings News Guidance

 

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