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Home/Stocks/INCY/Catalyst
PDUFAApproval decision

Zilurgisertib (ALK2 Inhibitor)

Fibrodysplasia Ossificans Progressiva

INCYIncyte Corporation
Expected catalystSeptember 26, 2026Company guidance: Sep 26, 2026

Catalyst overview

Event details

Drug or asset
Zilurgisertib (ALK2 Inhibitor)
Development stage
PDUFA
Event type
Approval decision
Indication
Fibrodysplasia Ossificans Progressiva

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Zilurgisertib (ALK2 Inhibitor) in Fibrodysplasia Ossificans Progressiva. The expected timing is based on the latest available company guidance and may change.

Development notes

06/04/26:- PROGRESS Ph2 Cohort 1 results at ENDO 2026 (Jun 13–16). PDUFA Sep 26, 2026. 06/14/26:- NDA accepted with Priority Review; PDUFA Sep 26, 2026. PROGRESS Week 48 Cohort 1 data presented.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

Incyte Corporation

INCY · NasdaqGS
Industry
Biotechnology
Pipeline assets
34
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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