uniQure’s stock has had a wild few days. On March 5, an FDA official publicly accused the company of “performing a distorted or manipulated comparison” in its phase 1/2 trial for Huntington’s disease drug AMT-130. Despite that, the stock closed up 18% that same day.
Then on March 6, news broke that Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), would be leaving the agency in April to return to academia. QURE jumped another 34% that day. By Monday, it was up 36%.
Prasad had directly overseen the regulatory handling of AMT-130. The FDA had told uniQure it would not approve the drug based on a comparison to natural history data — a position the company called a “key shift” from what had been agreed upon before new FDA leadership was installed.
The FDA had also requested that uniQure run a full phase 3 trial, a costly and time-consuming hurdle for a rare disease treatment.
Prasad’s departure appears to have changed the calculus for investors and analysts alike. RBC Capital analyst Luca Issi upgraded QURE from Sector Perform to Outperform, lifting his price target from $11 to $35. He now puts the odds of AMT-130 eventually getting approved at 50%.
“We believe that Prasad’s departure is likely to open up a more balanced discussion on risk/reward for HD,” Issi wrote.
Stifel analyst Paul Matteis called Prasad’s exit “a big win for biotech, especially for companies in the rare disease space.” He noted that Prasad had reportedly overruled internal FDA review teams to issue negative recommendations on several drugs.
Truist analysts said Prasad’s tenure “marked a sharp departure from the more flexible regulatory approach for rare and serious diseases” that had existed under his predecessor, Peter Marks. Multiple companies, they noted, faced shifting regulatory standards that had already been agreed on during earlier development talks with the agency.
The broader gene therapy sector caught a lift too. REGENXBIO (RGNX) rose 13% and Biohaven (BHVN) gained 23% on the news.
uniQure has a Type B meeting with the FDA scheduled for the second quarter of 2026. That meeting will be a key moment for the company to discuss the path forward for AMT-130.
Prasad is set to officially leave the agency in April.
On March 5, the same day the FDA official’s critical comments about uniQure’s trial design became public, the stock still closed up 18% — a sign that markets were already weighing Prasad’s influence on the outcome.
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