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PDUFAApproval decision

PYRUKYND (Mitapivat)

Sickle cell disease, Anemia

AGIOAgios Pharmaceuticals Inc.
Expected catalystNovember 1, 2026Company guidance: Nov 1, 2026

Catalyst overview

Event details

Drug or asset
PYRUKYND (Mitapivat)
Development stage
PDUFA
Event type
Approval decision
Indication
Sickle cell disease, Anemia

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for PYRUKYND (Mitapivat) in Sickle cell disease, Anemia. The expected timing is based on the latest available company guidance and may change.

Development notes

07/30/26:- REIGNITE Ph3 dosed first patient; Saudi SCD filing completed. PDUFA remains November 1, 2026.

Verification

Primary source

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

Open source

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Company

Agios Pharmaceuticals Inc.

AGIO · NasdaqGS
Industry
Biotechnology
Pipeline assets
12
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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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