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EBS FDA decision: Feb 13, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

OTC NARCAN Nasal Spray w/ carrying case was approved by the FDA for opioid overdose; the approval was announced on February 13, 2026.

Emergent BioSolutions Inc., OTC NARCAN Nasal Spray w/ carrying case · Opioid overdose.

Run-up into the decision (T-120 → T+5)

PDUFA 2/13/26$13.9$7.568/29/25
Daily close, T-120 (8/29/25) through T+5. Run-up high $13.9 on 1/8/26, low $7.56 on 9/12/25 (T-120 to T-1). FDA decision 2/13/26. Historical price action, not a forecast.
Positioning before the decision
On Dec 31, 2025, 14 days before the decision date, at-the-money options priced a move of ±10.1% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 60%). The stock closed +3.0% at the first close across the decision and -5.5% 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.

Key facts

FDA decision date2026-02-13
OutcomeApproved
Drug / candidateOTC NARCAN Nasal Spray w/ carrying case
CompanyEmergent BioSolutions Inc.
120-day run-up (T-120→T-1)+17.6%

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