Opco says buy Sarepta on selloff, views unchanged after article

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.