uniQure N.V.
QURENext catalyst
AMT-191
Fabry Disease
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Plus 2 more upcoming events in our data (BLA filing, PDUFA date).See the timeline
3 upcoming, 1 past
FDA PDUFA Date AMT-130 (priority review)
For Huntington's Disease EX-99. BLA filing. Extracted from: uniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for ifezuntirgene inilparvovec for the Treatment of Huntington's Disease
SourceBLA Filing - ifezuntirgene inilparvovec
For Huntington's disease. The FDA accepted uniQure's BLA for ifezuntirgene inilparvovec for Huntington's disease under Accelerated Approval with Priority Review, setting a PDUFA date of May 1, 2027, and tentatively plans an Advisory Committee meeting. The confirmatory trial (~200 patients, TFC primary endpoint at 36 months) is expected to begin screening by end of 2026.
SourceFDA PDUFA Date ifezuntirgene inilparvovec (priority review)
For Huntington's disease. BLA accepted. AI-extracted from: uniQure Announces FDA Acceptance and Priority Review of the Biologics License Ap
SourceUpcoming FDA decisions
How QURE's past catalysts played out
Market Overview
Stock performance and key metrics
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 | - | - |
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 PDUFA date expected May 1, 2027. 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.