pdufa.bio
HomeDecisions › IRWD 2026-05-27

IRWD FDA decision — May 27, 2026

✓ APPROVED

Ironwood Pharmaceuticals Inc. — LINZESS (Iinaclotide) · functional constipation (FC) in patients 2 to 5 ye.

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.

Key facts

FDA decision date2026-05-27
OutcomeApproved
Drug / candidateLINZESS (Iinaclotide)
CompanyIronwood Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+11.4%