Sarepta Therapeutics ( NASDAQ: SRPT ) added ~18% pre-market Wednesday as Morgan Stanly upgraded it after the company said that the FDA would not hold an advisory committee meeting on its marketing application for gene therapy SRP-9001.
Sarepta ( SRPT ) made these remarks with its Q4 2022 financials which came ahead of expectations for revenue but fell short of consensus for earnings.
The FDA has granted May 29, 2023, as the action date for the company’s biologics license application (BLA) for accelerated approval of SRP-9001 for treating ambulant individuals with Duchenne muscular dystrophy.
Detailing the progress on its review, Chief Executive Doug Ingram said that “as of the mid-cycle review, which is now complete, the FDA posed CMC questions which have been answered by Sarepta.”
“We see the lack of an AdCom and mgt. commentary following the mid-cycle review as supporting evidence that SRP-9001 can be approved based on the current clinical package,” Morgan Stanley analyst Matthew Harrison wrote in reaction.
Morgan Stanly upgrades Sarepta ( SRPT ) to Overweight from Equal Weight and raises its price target to $187 from $141 per share.
Seeking Alpha contributor Terry Chrisomalis reaffirmed his Strong Buy rating on Sarepta ( SRPT ) in January, citing the potential FDA approval of SRP-9001 as a key catalyst expected from the biotech this year.
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Sarepta gains 18% as Morgan Stanley upgrades citing FDA approval for gene therapy