Sarepta Swings to Profit but Faces Headwinds as Elevidys Sales Slip

Sarepta posts $331M net income in Q1 2026, beating revenue estimates, but Elevidys sales fall as FDA limits use; company shifts to traditional drug approvals for long-term stability.

Sarepta Therapeutics has returned to profitability, posting a net income of $331 million for the first quarter of 2026, or $2.88 per share, a sharp reversal from the $447.5 million loss recorded in the same period last year. The biotech group’s total revenue surged to $730.8 million, comfortably beating analyst expectations, driven largely by a hefty $400 million milestone payment from its partnership with Roche.

However, the market’s reaction was muted, with shares coming under pressure as investors zeroed in on the performance of the company’s flagship gene therapy, Elevidys. The treatment generated just $102 million in quarterly revenue, a decline from the prior year, as the U.S. Food and Drug Administration has restricted its use to ambulatory patients following cases of liver failure. Chief Executive Doug Ingram has cautioned that a swift recovery is unlikely, noting that the transition to the narrower patient population will take time to play out.

Beyond the near-term turbulence, Sarepta is laying the groundwork for a more stable future by shifting its regulatory strategy. In late April, the company submitted supplemental new drug applications for AMONDYS 45 and VYONDYS 53, seeking to convert their accelerated approvals into full, traditional marketing authorizations. The filings are backed by data from the ESSENCE study as well as real-world evidence from clinical practice. This move is designed to provide long-term revenue certainty for its core Duchenne muscular dystrophy portfolio.

The pipeline is also advancing on multiple fronts. The company has filed approval applications for two additional drug candidates, with the FDA expected to rule on them in early 2027. Meanwhile, new data from the siRNA platform are slated for the second half of 2026. Key milestones include the first patient dosing in the Huntington’s disease program during the first half of the year, fresh results from the ENDEAVOR study later in 2026, and updates on the limb-girdle muscular dystrophy candidate SRP-9003.

On the commercial side, physicians have now treated over 1,300 patients with Elevidys, though the process from referral to infusion currently takes about six months. Management is working to streamline these logistics. For the full year, Sarepta is maintaining its guidance for product revenue between $1.2 billion and $1.4 billion. With roughly $748 million in cash on hand, the company believes it can fund its research and development activities without tapping the capital markets in the near term.

The push toward traditional approvals marks a strategic inflection point for Sarepta, as it transitions from a speculative developer into a more established pharmaceutical player. Whether the market regains confidence in the stock will likely hinge on the safety data from the siRNA pipeline and the medical community’s trust in its therapies.