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IRWD FDA decision: May 27, 2026

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

LINZESS (Iinaclotide) was approved by the FDA; the approval was announced on May 27, 2026.

Ironwood Pharmaceuticals Inc., LINZESS (Iinaclotide).

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

PDUFA 5/27/26$5.39$3.0412/10/25
Daily close, T-120 (12/10/25) through T+5. Run-up high $5.39 on 1/27/26, low $3.04 on 3/24/26 (T-120 to T-1). FDA decision 5/27/26. Historical price action, not a forecast.
Positioning before the decision
On May 20, 2026, 7 days before the decision date, at-the-money options priced a move of ±35.4% through Jun 18, 2026 (the first listed expiry after the decision; ATM implied volatility 157%). The stock closed -4.9% at the first close across the decision and -15.9% 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 date2026-05-27
OutcomeApproved
Drug / candidateLINZESS (Iinaclotide)
CompanyIronwood Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+11.4%

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