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CYTK FDA Decision Approved · 2025-12-19

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

PDUFA 12/19/25$68.15$33.237/4/25
Daily close, T-120 (7/4/25) through T+5. Run-up high $68.15 on 11/27/25, low $33.23 on 8/13/25 (T-120 to T-1). FDA decision 12/19/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 5, 2025, 14 days before the decision date, at-the-money options priced a move of ±23.4% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 88%). The stock closed +0.8% at the first close across the decision and +1.5% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-12-19
DrugMYQORZO (Aficamten (CK-274)) - (SEQUOIA-HCM)
IndicationHypertrophic cardiomyopathy (HCM)
Outcome✓ Approvedprimary-sourced
Decision-day move+0.8%
T-120 run-up (low→high)+75.0% ($35.33→$68.15)
Market-cap tierSmall
Cohort decision-day move (history)3.7% median (n=302)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding CYTK, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Avoro Capital Advisors4,999,999$425.9 millionfiled August 14, 2026
RTW Investments2,862,003$243.8 millionfiled August 14, 2026
Baker Bros. Advisors211,267$18.0 millionfiled August 14, 2026
OrbiMed Advisors25,800$2.2 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was MYQORZO (Aficamten (CK-274)) approved by the FDA?

Yes. The FDA approved the application for MYQORZO (Aficamten (CK-274)) on December 19, 2025, per the FDA's own record. The primary source is linked on this page.

What was MYQORZO (Aficamten (CK-274)) under FDA review for?

The application covered Hypertrophic cardiomyopathy (HCM). The FDA approved the application on December 19, 2025.

How did CYTK stock react to the FDA decision?

On the decision day CYTK moved +0.8%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.