New Sarepta label weakens commercial narrative, says H.C. Wainwright

H.C. Wainwright says the FDA’s latest label action elevates Sarepta’s (SRPT) Elevidys into a heightened surveillance category, which materially weakens the drug’s commercial narrative. The boxed warning and removal of the non-ambulatory indication in the FDA’s updated Elevidys label were expected, but the “depth of revisions signals that the agency still sees unresolved uncertainty around liver injury even in ambulatory patients,” the analyst tells investors in a research note. H.C. Wainwright believes the new monitoring and safety language place Elevidys under active regulatory oversight that will slow “real-world throughput and strain capacity-limited centers.” The firm reiterates a Sell rating on Sarepta with a $5 price target