uniQure receives FDA alignment on AMT-130 accelerated approval pathway, plans Q3 BLA

Filed July 29, 2026 · Period ending July 29, 2026 · ~1 min read

Key Changes

• high

  FDA confirmed in July 2026 that a BLA submission for AMT-130 under accelerated approval is reasonable based on existing clinical data; company plans Q3 2026 submission. FDA seeks alignment on confirmatory study design prior to BLA, including consideration of standard-of-care control instead of sham procedure.

  Exhibit 99.1 view on EDGAR →
• high

  Closed $259M follow-on offering in June 2026 at $45.50/share (5.7M shares). Cash position expected to reach $810.3M at June 30, 2026, expected to fund operations into 2030.

  Exhibit 99.1 view on EDGAR →
• high

  Q2 2026 net loss widened to $81.1M ($1.22/share) from $37.7M ($0.69/share) in Q2 2025, driven by $16.0M loss on pre-funded warrants and unfavorable FX movements. Revenue rose to $5.8M from $5.3M.

  Exhibit 99.1 view on EDGAR →