Investing.com -- uniQure BV (NASDAQ: QURE) shares surged 36% Monday following reports that the head of the US Food and Drug Administration’s division of vaccines and gene therapies is leaving the agency, prompting multiple analyst upgrades across the biotech sector. REGENXBIO (NASDAQ: RGNX) rose 13% and Biohaven (NYSE: BHVN) gained 23%.

Vinay Prasad will depart the Center for Biologics Evaluation and Research next month to return to academia after a tenure marked by regulatory uncertainty for gene therapy companies.

RBC Capital analyst Luca Issi upgraded uniQure from Sector Perform to Outperform with a price target of $35.00, up from $11.00. The company recently faced setbacks after the FDA indicated it would not approve its Huntington’s disease treatment based on comparison to natural history, representing what uniQure called a "key shift" from prior communications before new FDA leadership was installed.

"We believe that Prasad’s departure is likely to open up a more balanced discussion on risk/reward for HD," Issi wrote, noting the analyst now sees a 50% chance the drug ultimately gets approved.

Stifel analyst Paul Matteis described Prasad’s departure as "a big win for biotech, especially for companies in the rare disease space." Matteis noted that various gene therapy and rare disease companies have faced pressure in the "FDA risk off" basket, with Prasad reportedly overruling review teams to issue negative recommendations.

Truist analyst commented that Prasad’s tenure "marked a sharp departure from the more flexible regulatory approach for rare and serious diseases" under his predecessor Peter Marks. Under Prasad’s leadership, multiple companies faced shifting regulatory standards that had been previously agreed upon during developmental interactions.

uniQure has a Type B meeting scheduled for the second quarter.