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CRNX FDA Decision Approved · 2025-09-25

Updated September 23, 2026·next FDA decision on the calendar

Price into the decision (T-120)

Daily close, T-120 (4/10/25) through T+5. Run-up high $36.5 on 9/9/25, low $25.56 on 4/15/25 (T-120 to T-1). FDA decision 9/25/25. Historical price action, not a forecast.

Positioning before the decision

On Sep 11, 2025, 14 days before the decision date, at-the-money options priced a move of ±18.8% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 75%). The stock closed +2.0% at the first close across the decision and +18.3% 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 date2025-09-25

DrugPALSONIFY (paltusotine)

IndicationAcromegaly

Outcome✓ Approvedprimary-sourced

Decision-day move+2.0%

T-120 run-up (low→high)+56.0% ($26.85→$45.91)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA219070, action date 2025-09-25

Market-cap tierMid

Cohort decision-day move (history)2.1% median (n=234)

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 →

Questions

Was PALSONIFY (paltusotine) approved by the FDA?

Yes. The FDA approved the application for PALSONIFY (paltusotine) on September 25, 2025. The primary source is linked on this page.

What was PALSONIFY (paltusotine) under FDA review for?

The application covered Acromegaly. The FDA approved the application on September 25, 2025.

How did CRNX stock react to the FDA decision?

On the decision day CRNX moved +2.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.