# Matt Kapusta

Type: Person

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/matt-kapusta
Canonical HTML page: https://getbiobrief.com/entity/matt-kapusta

## Timeline

- **2026-06-17**: FDA accepts AMT-130 Phase 1/2 data for BLA — The FDA reversed its earlier requirement for additional data, agreeing existing clinical data supports a near-term BLA submission for Huntington’s gene therapy.
- **2026-Q2**: FDA Type B Meeting — Planned follow-up meeting to define the Phase III pathway for AMT-130 in Huntington's disease.
- **2026-03-02**: Earnings Release — Company announces 2025 results and provides update on FDA Type A meeting.
- **2026**: AMT-260 Data — Clinical data expected from the Phase I/IIa study in refractory mesial temporal lobe epilepsy.
- **2026**: Planned BLA submission in Q3 2026 — UniQure intends to submit a Biologics License Application for AMT-130 in the third quarter, pending alignment meeting on confirmatory study design.
- **2025-12-31**: Fiscal Year End — uniQure closes 2025 with $622.5M in cash and equivalents.

## Recent coverage (2 stories)

### UniQure Jumps 78% as FDA Accepts Phase 1/2 Data for AMT-130 BLA
2026-07-12 05:40:50 · Sentiment: Strongly positive · Impact: 8/10 · Sources: 2

FDA’s acceptance of existing clinical data for uniQure’s AMT-130 gene therapy signals a major regulatory win, with the company on track for a BLA submission in Q3 2026 and a potential first-in-class approval for Huntington’s disease.
Full story: https://getbiobrief.com/story/uniqure-amt130-fda-phase1-2-data-bla-bio

### uniQure Eyes 2029 Runway as FDA Talks for Huntington's Gene Therapy Continue
2026-03-03 00:54:14 · Sentiment: Neutral · Impact: 6/10 · Sources: 2

uniQure reported a robust $622.5 million cash position, extending its operational runway into late 2029. While clinical data for its Huntington’s disease candidate AMT-130 remains strong, the company is still seeking regulatory alignment with the FDA on a definitive Phase III pathway.
Full story: https://getbiobrief.com/story/uniqure-2025-earnings-huntingtons-gene-therapy-update

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