← Back to Calendar

MYQORZO (aficamten)

Cytokinetics · $CYTK
Priority Review Fast Track Breakthrough Therapy NDA
PDUFA Date
December 26, 2025
Date Status
108d ago (past)
Review Type
Priority (6 mo)
90%
Baseline PoA
NDA priority review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
PDUFA date was December 26, 2025

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$65.01 +71.76%
+$27.16 today
Day: $63.95 – $65.50
Market Cap
N/A
Shares out: 123.16M
Float: 122.30M
52-Week Range
$29.31
$70.98
Current price is at 86% of 52-week range
Avg Volume
1.87M
Beta
0.48
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Track $CYTK catalysts → get weekly FDA alerts Subscribe Free on Substack →

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.

Discussion

Share your analysis, research, or questions about this catalyst. No account required.

Rate limit: 5/hr per email
Loading comments...
← Back to Full Calendar