Sarepta shares fall as CEO exits amid Elevidys sales plunge
Leadership transition and 33% quarterly decline in gene therapy revenue add to biotech's turbulent year
Sarepta Therapeutics chief executive Doug Ingram will retire by the end of 2026, capping a tumultuous period for the biotechnology company as it grapples with declining sales of its flagship gene therapy Elevidys and heightened regulatory scrutiny.
The announcement, made during the company's fourth-quarter earnings call on Wednesday, came alongside news that Elevidys revenue fell to $110.4 million in the fourth quarter of 2025, a 33% decline from the prior year period. Sarepta shares dropped approximately 4% in after-hours trading, extending a collapse that has erased more than 80% of the stock's value over the past year.
The sales decline stems directly from a November 2025 FDA decision that added a boxed warning for serious liver injury to Elevidys's label and removed the therapy's indication for non-ambulatory Duchenne muscular dystrophy patients. The agency's action followed reports of fatal acute liver failure in non-ambulatory patients who received the gene therapy. Sarepta voluntarily suspended shipments to non-ambulatory patients in June 2025.
For the full year 2025, Elevidys generated $898.7 million in revenue, contributing to total company revenues of $2.2 billion, a 16% increase year-over-year that was buoyed by Sarepta's established PMO franchise of exon-skipping therapies. However, the Elevidys shortfall overshadowed this growth, as total quarterly revenues decreased by $215.5 million compared with the fourth quarter of 2024.
"Sarepta enters 2026 from a position of strength," Ingram said during the earnings call, citing the company's $954 million in cash and investments and its expectation to become cash flow positive and profitable on a non-GAAP basis in 2026. The company provided revenue guidance of $1.2 billion to $1.4 billion for 2026 across its approved therapies.
Analysts have grown increasingly cautious on Sarepta's prospects. In July 2025, JPMorgan downgraded the stock from Neutral to Underweight, citing negative headlines and regulatory concerns, while other firms including Citi maintained Sell ratings. As of February 2026, the consensus analyst rating is "Hold" with an average price target of approximately $21, representing modest upside from current levels around $19 but far below the stock's 52-week high of $109.55.
The leadership transition adds another layer of uncertainty. Ingram, who has led Sarepta through pivotal Elevidys approval battles, told analysts that a search for his successor is underway. The announcement comes as the company works to execute a recovery strategy focused on educational initiatives to drive Elevidys adoption among ambulatory patients, its remaining approved indication.
"Without our educational efforts, we would expect to track toward the lower end of this range," management said regarding 2026 revenue guidance, according to earnings call transcript details. "The timing of initiatives could push it to the higher end, with the impact of these educational efforts expected to be more noticeable in the second half of 2026."
The company has initiated a new study cohort to evaluate an enhanced immunosuppression regimen for non-ambulatory patients, aiming to potentially resume dosing for this population with FDA approval. Sarepta also reported positive three-year data from the EMBARK study, showing durable slowing of disease progression in ambulatory Duchenne patients treated with Elevidys.
The FDA's Elevidys restriction marked a significant setback for the gene therapy field, which has struggled to balance breakthrough treatments with safety concerns in rare diseases. Sarepta's experience has become a case study in the challenges of commercializing high-cost gene therapies amid intense regulatory and public scrutiny.
For investors, the coming months will focus on the CEO search process, the success of Sarepta's educational commercial push, and regulatory developments around potential resumed access for non-ambulatory patients. With the stock trading near its 52-week low of $10.42 and down more than 80% from its 2025 peak, the biotechnology company faces a steep path to restoring investor confidence.