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uniQure Submits BLA for Huntington's Disease Gene Therapy

uniQure announced the submission of a biologics license application, or BLA, to the FDA for the accelerated approval of ifezuntirgene inilparvovec, an investigational gene therapy for the treatment of Huntington's disease. The company also announced that its Marketing Authorization Application, or MAA, for ifezuntirgene inilparvovec has been submitted to the United Kingdom's Medicines and Healthcare products Regulatory Agency. The company has requested priority review for the BLA. If granted, priority review would shorten the FDA review cycle to six months following the FDA's 60-day BLA filing review period.

uniQure Reports Q2 Revenue of $5.84M, Exceeds Expectations

Reports Q2 revenue $5.84M, consensus $4.71M. "This has been a defining quarter - not just for uniQure, but for the Huntington's disease community," said Matthew Kapusta, chief executive officer at uniQure. "Following a productive Type B meeting with the FDA, we remain on track to submit our BLA for AMT-130 in the third quarter - a milestone that reflects years of rigorous science, disciplined execution, and an unwavering commitment to the patients and families living with this devastating disease. With four-year data expected in September and the U.K. regulatory activities progressing as planned, we enter the second half of 2026 with real momentum and a clear line of sight to potentially bringing this therapy to the people who need it."

Deal Size Increased to $225M

The deal size was increased to $225M from $150M and priced below the last closing price of $49.04 per share. Leerink and Stifel are acting as joint book running managers for the offering.