Sarepta Cuts 36% of Workforce and Finally Agrees to FDA Request to Halt All Elevidys Shipments Following Patient Deaths

Sarepta Therapeutics has been having a busy summer, facing corporate restructuring and regulatory scrutiny over its Duchenne muscular dystrophy gene therapy, Elevidys (delandistrogene moxeparvovec).

Last week, Sarepta announced a sweeping company overhaul that will involve approximately 500 layoffs — about 36% of the company’s workforce — by early 2026.

And this week, the company made the decision to give in and comply with the FDA’s request to temporarily pause all shipments of its Duchenne muscular dystrophy (DMD) gene therapy, Elevidys (delandistrogene moxeparvovec), this week after it was linked to two recent patient deaths.

Sarepta’s restructuring plan is expected to generate annualized savings of roughly $400 million, beginning in 2026. The company shake-up comes after Elevidys received a boxed warning from the FDA due to the risk of acute liver failure after the deaths of two non-ambulatory teens who had received the therapy.

Sarepta had since paused Elevidys shipments but only for certain older and non-ambulatory patients. It convened an expert panel that has proposed new immunosuppressive protocols, including the addition of sirolimus, in hopes of mitigating serious immune-related liver complications.

While the FDA has not yet approved the new regimen, discussions are ongoing, and Sarepta aims to reopen non-ambulatory trials if safety concerns are addressed.

However, late last week, the FDA requested that Sarepta pause all shipments of the gene therapy. Sarepta initially refused and said it would continue supplying the treatment to ambulatory (still walking) patients.

But the company ended up complying with the request on Monday, announcing it will voluntarily and temporarily pause all Elevidys shipments in the US.

Related: Sarepta’s Gene Therapy Elevidys Under Scrutiny After Patient Death

“As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of Elevidys was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options,” said Sarepta’s CEO Doug Ingram in the statement announcing the complete pause on shipments.

“It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

Sarepta said the proactive step will give Sarepta the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the Elevidys safety labeling supplement process.

Sarepta is also working to update Elevidys’ safety label in agreement with the FDA.

Through the restructuring, Sarepta hopes to save an additional $300 million through the de-prioritization of several research programs, including those in a group of muscle-wasting disorders, including limb-girdle muscular dystrophy and other early-stage gene therapies.

“Faced with environmental changes, we have decided to act decisively, implementing a focused strategy to ensure Sarepta remains a vibrant, financially enduring, patient-centric organization dedicated to improving the lives of those with rare genetic diseases,” said Ingram last week.

Despite the challenges, Sarepta remains committed to Elevidys and projects the gene therapy could still generate at least $500 million in annual revenue through 2027, even under the current limited ambulatory-only label.

In Q2 2025, the company reported preliminary product revenues of $513 million, with Elevidys contributing $282 million, significant declines from Q1 2025, when total revenues reached $611.5 million with Elevidys sales hitting $375 million.

According to a July 17 note from analysts at William Blair, it is highly unlikely that Elevidys will be entirely withdrawn from the market. They also believe investors now have greater confidence in Sarepta’s ability to meet its long-term debt obligations.

In tandem with the restructuring, Sarepta is shifting its strategic focus toward RNA-based therapies, specifically small interfering RNA (siRNA) programs. The company sees significant promise in siRNA platforms for treating diseases such as myotonic dystrophy type 1, idiopathic pulmonary fibrosis, Huntington’s disease and other fibrotic and neuromuscular disorders.

Several of the programs are being developed in collaboration with Arrowhead Pharmaceuticals. By concentrating resources on these assets, Sarepta hopes to drive future growth while reducing its dependence on high-risk gene therapy programs.

Ingram said, “We will continue to drive performance of Elevidys and our three [phosphorodiamidate morpholino oligomers] PMOs in service of the Duchenne community those therapies benefit, and with our financial performance, we will advance our high-value, focused pipeline of programs for rare genetic diseases, primarily relying on the siRNA platform, while ensuring we meet our financial obligations.”

According to reporting by Fierce Biotech, Sarepta confirmed the layoffs following nearly a full day of speculation sparked by a Reddit post that quickly circulated among industry professionals and journalists.

According to the post, an employee attempting to request time off in the company’s system discovered they had been marked as “terminated” as of the previous Friday when the application failed to process.

In a statement to Fierce Biotech, a Sarepta spokesperson explained: “As efforts were underway prepare severance packages, if an employee logged in to Workday, they may have seen their vacation balance at zero (colleagues are paid out for unused vacation). We did clarify this with impacted colleagues earlier today — we sought to treat everyone with care and dignity and apologized if the impact from seeing that information caused additional anxiety or confusion.”

After the news broke, industry peers extended a hand — in a LinkedIn post, Charles Achibiri, director of oligonucleotide drug substance at Stoke Therapeutics, shared that the company was hiring: “Sarepta Therapeutics employees who are losing their jobs today, Stoke Therapeutics is hiring. Feel free to reach out.”

Market reaction to the announcement was positive, with Sarepta shares rebounding sharply after months of steep decline. The stock, which had been down more than 80% year-to-date, rose by more than 30% in post-market trading following the news.

Analysts and investors have interpreted the restructuring as a necessary and pragmatic step to stabilize the company’s operations and ensure long-term viability.

However, some observers remain cautious, noting that Sarepta’s ability to regain momentum will depend on the FDA’s acceptance of its proposed Elevidys safety protocols and the success of its newly prioritized siRNA pipeline.