Sarepta Therapeutics (SRPT) says adverse event report was erroneously submitted to FDA's FAERs

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Go back to Sarepta Therapeutics (SRPT) says adverse event report was erroneously submitted to FDA's FAERs

Sarepta Therapeutics Comments on Erroneous Submission to US FDA Adverse Event Reporting System (FAERS)

August 8, 2019 3:27 PM EDT

CAMBRIDGE, Mass., Aug. 08, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, was informed earlier today that an adverse event report was erroneously submitted to the FDAs adverse event reporting system (FAERs), a post-marketing surveillance database for approved therapies.  Our investigation to date indicates that this report was not submitted to the FAERs database by a Sarepta employee or the studys principal investigator.  

The submission reported a case of rhabdomyolysis in a participant in Sareptas Study SRP-9001-102, a... More