uniQure says FDA finds AMT-130 Phase I/II data insufficient
as 2025 results show loss and cash runway to 2H 2029
- FDA deemed AMT-130 Phase I/II data versus an external control insufficient to support a marketing application.
- Agency recommended a new randomized sham surgery-controlled trial, and uniQure plans further talks on Phase III design.
- uniQure ended 2025 with $622.5 million in cash, expected to fund operations into the second half of 2029.
- 2025 revenue totaled $16.1 million, while the company recorded a $199.0 million net loss for the year.
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