uniQure N.V.
QUREDrugs in Pipeline
3
Phase 3 Programs
0
Upcoming Catalysts
3
Next Catalyst
Sep 30, 2026
11dMarket Overview
Stock performance and key metrics
3 upcoming, 0 past
BLA Filing
uniQure announced plans to submit a BLA for its Huntington's disease gene therapy in Q3 2026 following an FDA policy reversal, though a confirmatory study is still required before submission.
SourceAMT-162 Phase 2 Est. Readout
Primary completion for AMT-162 trial (NCT06100276) in Amyotrophic Lateral Sclerosis
Source1 more catalyst beyond 14 days
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How QURE's past catalysts played out
AMT-191
Fabry Disease
rAAV2/5-hNAGLU
Sanfilippo Syndrome B
AMT-162
Amyotrophic Lateral Sclerosis
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
AMT-191 | Phase 2 | Fabry Disease | - | - |
rAAV2/5-hNAGLU | Phase 2 | Sanfilippo Syndrome B | - | - |
AMT-162 | Phase 2 | Amyotrophic Lateral Sclerosis | - | - |
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in uniQure N.V.'s drug pipeline?→
CatalystAlert tracks 3 drug candidates in uniQure N.V.'s (QURE) pipeline across Phase 2. Its lead program is AMT-191 (Phase 2). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is uniQure N.V.'s next FDA catalyst?→
uniQure N.V.'s (QURE) next tracked catalyst is a BLA Filing expected September 30, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track QURE biotech catalysts?→
Add QURE to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow uniQure N.V.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.