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Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

 
• By Brenda Sandburg

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Close up of girl's hand placing the last jigsaw puzzle piece with word Dispute Resolution
Sarepta did not publicly disclose that it made a formal dispute resolution request over Vyondys 53 complete response letter

Sarepta Therapeutics Inc. had not revealed that it submitted a formal dispute resolution request appealing the US Food and Drug Administration's complete response letter for Vyondys 53 (golodirsen) so the announcement that the agency had approved the Duchenne muscular disease drug was surprising news.

Companies must file a Form 8-K with the Securities and Exchange Commission to announce certain types of material events. So this raises a question of whether Sarepta's challenge of FDA's...

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