Shares of Sarepta Therapeutics are lower today after STAT reported FDA staffers had doubts on the approvability of the company’s gene therapy SRP-9001 for Duchenne muscular dystrophy via an accelerated approval pathway, Oppenheimer analyst Hartaj Singh the analyst tells investors in a research note. The FDA staff’s distrust of Sarepta is due to company’s inability to quickly start confirmatory trials for the three exon-skipping agents approved since 2016, says the firm. While it understands the FDA’s concerns with the approved drugs, Opco points to Sarepta’s "comprehensive" SRP-9001 EMBARK Phase 3 trial-already ongoing as evidence that the company has listened and paid heed to FDA feedback. The firm believes the FDA panel is being held to provide clarity through a thorough review and discussion around SRP-9001’s "comprehensive" data package. It views the selloff today in shares of Sarepta as a buying opportunity and says the STAT article does not change its view. Opco has an Outperform rating on the shares with a $180 price target. The stock in midday trading is down 7% to $127.50.
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