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PDUFAApproval decision

Camzyos/Mavacamten (MYK-461) (Myosin Inhibitor)

Adolescent Obstructive Hypertrophic Cardiomyopathy

BMYBristol-Myers Squibb
Expected catalystSeptember 30, 2026Company guidance: Sep 30, 2026

Catalyst overview

Event details

Drug or asset
Camzyos/Mavacamten (MYK-461) (Myosin Inhibitor)
Development stage
PDUFA
Event type
Approval decision
Indication
Adolescent Obstructive Hypertrophic Cardiomyopathy

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Camzyos/Mavacamten (MYK-461) (Myosin Inhibitor) in Adolescent Obstructive Hypertrophic Cardiomyopathy. The expected timing is based on the latest available company guidance and may change.

Development notes

01/11/26:- SCOUT-HCM Ph3 in adolescent oHCM met primary endpoint; full results at future congress, regulatory discussions planned. 03/20/26:- Full Phase 3 SCOUT-HCM results at ACC 2026 on March 29, 2026. 05/29/26:- FDA accepted priority sNDA for adolescent oHCM; PDUFA set for September 30, 2026.

Verification

Primary source

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

Open source

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Company

Bristol-Myers Squibb

BMY · NYSE
Industry
Biotechnology
Pipeline assets
62
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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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