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MYQORZO (aficamten)

Cytokinetics · $CYTK

Priority Review Fast Track Breakthrough Therapy NDA

PDUFA Date

December 26, 2025

Time Remaining

88d ago

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical NDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Obstructive hypertrophic cardiomyopathy (oHCM)

Key Notes

FDA APPROVED December 19, 2025 — 7 days before PDUFA target date of December 26, 2025. MYQORZO is Cytokinetics' first FDA-approved product. Cardiac myosin inhibitor — only the second of its class (alongside BMS Camzyos). SEQUOIA-HCM Phase 3 showed superiority over metoprolol. European Commission approved in February 2026. China NMPA approved December 17, 2025. Next catalyst: ACACIA-HCM readout (non-obstructive HCM) expected Q2 2026.

⚠️ 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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