Sarepta to cut 36% of staff, add black-box warning to Elevidys

Sarepta Therapeutics is laying off 36% of staff—500 employees—a move expected to be “substantially completed” by the end of Q3, it announced in a July 16 8-K filing.

As part of these changes, the company is scrambling its C-suite:

• The company is terminating Dallan Murray, EVP and chief customer officer, though he will remain a consultant through January 2026.
• Ian Estepan, former EVP and CFO, is now president and chief operating officer.
• Former president and CEO Douglas Ingram will solely be CEO from now on.
• Ryan Wong has taken over Estepan’s old positions.
• Louise Rodino-Klapac is now the company’s president of R&D and technical operations. She was previously EVP and chief scientific officer, and headed R&D.

Sarepta will also add a black-box warning—the most serious kind—for acute liver injury and failure for Elevidys, per the FDA’s request. Elevidys, the company’s most profitable product, is the only FDA-approved gene therapy for deadly muscle-wasting disease Duchenne muscular dystrophy.

What’s going on? Elevidys has been somewhat controversial since its June 2024 approval.

Then-director of the Center for Biologics Evaluation and Research Peter Marks overruled his staff to give the drug full approval for ambulatory patients ages 4+ and accelerated approval to nonambulatory patients.

This happened even though the FDA’s clinical and clinical and clinical pharmacology review team wrote it had “no satisfactory data to support effectiveness claims for all ages and for nonambulatory patients,” Stat reported at the time.

In the year since the drug’s approval, two nonambulatory patients taking Elevidys died of acute liver failure. One case was disclosed in March and the other in June.

After the second death, Sarepta announced it was pausing shipping Elevidys to nonambulatory patients.

Sarepta added in its July 16 update that an internal expert committee has devised an “enhanced immunosuppressive regimen” for nonambulatory patients to take in order to reduce their chances of acute liver failure.

The company plans to submit that to the FDA and start gathering evidence on how to safely resume the treatment in patients who can’t walk.

In total, more than 900 people have taken the drug worldwide, according to the company.