Sarepta Therapeutics has appointed Michael Severino, M.D., as its new chief executive, effective July 28, replacing longtime leader Doug Ingram.
Ingram announced his planned retirement citing what he described as an “ironic twist of fate” involving the health of his family members, prompting the leadership search.
Severino arrives at Sarepta following his role leading Flagship Pioneering’s Tessera Therapeutics, where he gained significant experience in genetic medicine.
Before Tessera, Severino served as Vice Chairman and President at AbbVie, where he oversaw research, development, and corporate strategy at the pharmaceutical giant.
During his AbbVie tenure, Severino helped shepherd more than a dozen approved therapies to market, including Rinvoq, Skyrizi, and Venclexta.
He brings over 25 years of biopharmaceutical experience to Sarepta, alongside a deep track record in genetics, genomics, computational biology, and precision medicine.
Severino’s arrival comes at a critical moment for Sarepta, which has spent the past year managing serious commercial and regulatory headwinds around its Duchenne muscular dystrophy gene therapy Elevidys.
Liver safety signals linked to Elevidys ultimately resulted in an FDA label restriction, barring non-ambulatory DMD patients in the United States from accessing the therapy.
That label change came roughly six months after Sarepta and partner Roche halted Elevidys use in non-ambulatory patients following reports of deaths from acute liver failure.
The safety controversy has cast a long shadow over Elevidys sales, which analysts had flagged as a source of concern heading into the current year.
Sarepta reported first-quarter revenue of $730.8 million, down from nearly $745 million in the same period the prior year, attributing the decline to lower Elevidys volumes following the label update.
The revenue drop signals the commercial reality Severino must confront immediately as he settles into the chief executive role and seeks to stabilise the business.
Beyond Elevidys, Severino must also steer Sarepta through a regulatory process involving two exon-skipping drugs, Amondys 45 and Vyondys 53, both of which treat Duchenne muscular dystrophy.
Sarepta filed applications to convert both drugs from accelerated to full approval status, despite missing the primary endpoint of a confirmatory trial known as Essence.
The FDA has assigned a target decision date of February 28, 2027, for those applications, giving Severino a defined but demanding regulatory timeline to manage.
The accumulated challenges mean Severino inherits not just a commercial recovery task but also an environment of intense external scrutiny over Sarepta’s safety communications and governance practices.
Investors and analysts will be watching closely as the new chief executive charts a path forward for a company facing questions on multiple fronts simultaneously.