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INSM FDA Decision Approved · 2025-08-12

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 8/12/25$112.89$64.812/25/25
Daily close, T-120 (2/25/25) through T+5. Run-up high $112.89 on 8/11/25, low $64.81 on 4/16/25 (T-120 to T-1). FDA decision 8/12/25. Historical price action, not a forecast.
Positioning before the decision
On Jul 29, 2025, 14 days before the decision date, at-the-money options priced a move of ±11.2% through Aug 15, 2025 (the first listed expiry after the decision; ATM implied volatility 65%). The stock closed +8.1% at the first close across the decision and +12.7% 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 date2025-08-12
DrugBRINSUPRI (Brensocatib) - (ASPEN)
IndicationNon-Cystic Fibrosis Bronchiectasis (NCFBE)
Outcome✓ Approvedprimary-sourced
Decision-day move+8.1%
T-120 run-up (low→high)+97.0% ($64.81→$127.8)
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.

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Questions

Was BRINSUPRI (Brensocatib) - (ASPEN) approved by the FDA?

Yes. The FDA approved the application for BRINSUPRI (Brensocatib) - (ASPEN) on August 12, 2025. The primary source is linked on this page.

What was BRINSUPRI (Brensocatib) - (ASPEN) under FDA review for?

The application covered Non-Cystic Fibrosis Bronchiectasis (NCFBE). The FDA approved the application on August 12, 2025.

How did INSM stock react to the FDA decision?

On the decision day INSM moved +8.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.