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MYQORZO (supplemental) (aficamten (MAPLE-HCM sNDA))

Cytokinetics · $CYTK
Standard Review Fast Track sNDA
PDUFA Date
October 30, 2026
Time Remaining
193 days
Review Type
Standard (10 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$66.71 +68.97%
+$27.23 today
Day: $65.14 – $67.04
Market Cap
N/A
Shares out: 123.16M
Float: 122.47M
52-Week Range
$29.31
$70.98
Current price is at 90% 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.
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Indication

Obstructive HCM — aficamten vs standard of care beta-blocker as monotherapy alternative

Key Notes

sNDA submitted Q1 2026. PDUFA estimated Q4 2026 (company guidance: "regulatory approval for sNDA for MAPLE-HCM expected by Q4 2026"). MAPLE-HCM Phase 3 demonstrated superiority of aficamten to standard of care beta-blocker (metoprolol) in improving peak exercise capacity (pVO2) in oHCM — positions MYQORZO as a first-line option rather than only add-on therapy. Significant label expansion opportunity. ACC 2026 data presentations included new MAPLE-HCM analyses on exercise capacity and treatment interruption flexibility.
⚠️ 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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