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MYQORZO (aficamten)

Cytokinetics · $CYTK

Standard Review Advisory Committee

PDUFA Date

June 3, 2026

Time Remaining

71 days

Review Type

Standard (10 mo)

92%

Baseline PoA

Historical NDA/BLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Obstructive hypertrophic cardiomyopathy (oHCM)

Key Notes

AdCom was expected ~2 months before the original August 2026 PDUFA date. Drug was FDA approved December 19, 2025 (PDUFA date: Dec 26, 2025) — ahead of any AdCom. MYQORZO now commercial in US and approved in EU and China. No AdCom was ultimately needed.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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