Sarepta stock plummeted Wednesday on a "double whammy" that includes its trimmed 2025 sales outlook and a critical Food and Drug Administration appointment.
On today's stock market, shares of Sarepta Therapeutics tumbled 21.5% to 36.72. That followed a nearly 27% drop on Tuesday after FDA Commissioner Marty Makary picked Vinay Prasad to head up the FDA's Center for Biologics Evaluation and Research.
Prasad is a well-known critic of the FDA's accelerated approval pathway and Sarepta's Elevidys, in particular. Elevidys is a gene therapy that treats Duchenne muscular dystrophy. Prasad's views are a "dichotomous contrast" with Peter Marks, the prior CBER director who championed accelerated approvals for genetic medicines, Needham analyst Gil Blum said in a report.
The news sent Sarepta stock down to its lowest point since August 2017.
Sarepta Stock Is Tied To Elevidys
During the first quarter, Elevidys generated $375 million in sales. But that missed forecasts for $421.6 million, according to FactSet. Sarepta also recorded $4 million in royalty sales from Roche.
The light Elevidys sales come after a teenager died following treatment with Elevidys. Plus, it's taking longer for patients to get approved for Elevidys treatment. Needham's Blum says patients are now waiting four to six weeks from the time they request Elevidys to actual infusion.
As a result, Sarepta lowered its full-year sales outlook to $2.3 billion to $2.6 billion, down from its previous forecast for $2.9 billion to $3.1 billion.
William Blair analyst Sami Corwin noted Sarepta stock has already been under pressure due to "macroeconomic overhangs."
"The guidance revision is stark, suggesting a 20% decline from the previously issued product revenue guidance," she said in a report. "However, if the prolonged timelines translate to better patient safety and monitoring, we are supportive of a slightly delayed revenue stream."
She has an outperform rating on Sarepta stock.
Price-Target Cut
Across all products, Sarepta reported $744.9 million in sales, up 80% year over year, and easily above the Street's call for $687.5 million. But losses were also wider than expected at $4.60 per share, vs. expectations for a per-share loss of $3.21.
RBC Capital Markets analyst Brian Abrahams slashed his price target on Sarepta stock to 58 from 87, and kept his sector perform rating.
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