Shares of several biotech and pharmaceutical companies surged on Monday following Friday's confirmation that Dr. Vinay Prasad, the embattled director of the Food and Drug Administration's Center for Biologics Evaluation and Research, will leave the agency at the end of April. FDA Commissioner Marty Makary announced Prasad's departure in a late Friday email to agency staff, stating that he would return to his academic post at the University of California, San Francisco.
The market reaction was immediate and pronounced. UniQure, which had been engaged in a public regulatory standoff with Prasad's division over requirements for its Huntington's disease gene therapy AMT-130, saw its shares surge as much as 70% in after-hours trading Friday before continuing higher in Monday's premarket session, rising approximately 31% to $18.75. Regenxbio gained approximately 29%, and Moderna extended gains of more than 5% it had logged at the open, adding to what has been a strong year-to-date performance for the mRNA drug developer.
Prasad's tenure at CBER had been marked by a series of high-profile controversies that roiled the biotech sector. His division rejected or issued complete response letters for applications from more than half a dozen companies developing therapies for rare and hard-to-treat diseases, frequently citing insufficient trial data or demanding additional studies in ways that industry participants said contradicted earlier guidance from the agency. The unpredictability of the regulatory process under his leadership had raised the cost of capital for early-stage biotech firms and created significant uncertainty for drug developers with pending applications.
Among the most prominent flashpoints was Prasad's initial refusal to accept Moderna's application for review of a new mRNA-based influenza vaccine — an unusual step that prompted the company to publicly challenge the FDA's decision and vow to formally contest the rejection. Within days, the agency reversed course, agreeing to accept the application for review pending an additional study from Moderna. The episode drew criticism from both industry executives and lawmakers who argued it illustrated an incoherent regulatory posture.
Separately, Prasad's CBER became embroiled in a contentious public dispute with UniQure over requirements for a new clinical trial that the company said would involve performing a sham surgery on Huntington's disease patients — a demand characterized by patient advocacy groups as medically and ethically inappropriate. Commissioner Makary subsequently told CNBC that the FDA does not require randomized controlled trial models for all rare diseases and emphasized the agency's commitment to regulatory flexibility, a comment widely interpreted as distancing the leadership from Prasad's stance.
Commissioner Makary stated that a successor will be named before Prasad's departure and highlighted several policy accomplishments during the tenure, including a new framework for individualized medicine and a record number of approvals from CBER in December 2025. Investors are now focused on whether the incoming CBER leadership will reconsider previously denied applications and whether the agency's overall posture toward gene therapy and vaccine approvals will normalize. Analysts noted that a more predictable regulatory environment would lower the risk premium embedded in biotech valuations and could support a broad sector re-rating.