FDA Official Who Halted Sarepta’s Gene Therapy Resigns Amid Backlash Over Access To Duchenne Treatment
Vinay Prasad resigned from the FDA after just two months in the role, following backlash over blocking access to Sarepta’s gene therapy for critically ill patients.
Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing backlash over how he handled Sarepta’s Elevidys, the only approved gene therapy for Duchenne muscular dystrophy.
“Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” Department of Health and Human Services spokesperson Andrew Nixon said in a statement.
The resignation follows weeks of mounting pressure after Prasad and FDA Commissioner Marty Makary asked Sarepta to pause shipments of Elevidys earlier this month following three reported patient deaths, two of which were linked to liver failure, according to a Bloomberg report.
Sarepta initially resisted the request but later complied. After the pause, patient groups and conservative outlets slammed the FDA for blocking what they saw as a last hope for kids with a devastating disease.
The Wall Street Journal editorial board went so far as to call the move a “mugging,” warning it could chill future drug innovation. Conservative influencers, including activist Laura Loomer, resurfaced past social media posts from Prasad supporting progressive politicians, accusing him of “dismissing the urgency of patient access to life-saving treatments.”
A few days later, the FDA reversed course and allowed Sarepta to resume shipments of Elevidys, but only for children who can still walk. The agency is still in discussions with Sarepta over updated safety labeling, and the pause remains in place for non-ambulatory patients.
Prasad, a former UCSF epidemiologist and prominent vaccine critic, had previously questioned the approval of Elevidys and made inflammatory remarks online earlier this year, saying the treatment “seems to be killing kids.”
He was appointed in May to replace Peter Marks, who was removed from the Center for Biologics Evaluation and Research (CBER) after conflicting with Health and Human Services Secretary Robert F. Kennedy Jr. over vaccine policy.
During his brief tenure, Prasad and Makary had sought to overhaul the FDA’s approach to vaccines, arguing for tighter evidence standards.
Prasad also overruled FDA staff to restrict COVID-19 vaccine approvals from Moderna and Novavax to high-risk groups only. The decision, however, drew fire from both public health advocates and Kennedy-aligned skeptics.
On Stocktwits, retail sentiment for Sarepta was ‘extremely bullish’ late Tuesday amid a 1,459% surge in 24-hour message volume.
Sarepta’s stock has declined 87.2% so far in 2025.
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