Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Meloxicam (MR-107A-02) in Moderate-to-severe acute surgical pain. The expected timing is based on the latest available company guidance and may change.
8/1/25- Present data at PAINWeek 2025 on September 4, 2025. 02/26/26:- PR No update. 05/07/26:- PR No update. 05/18/26:- FDA accepted NDA; PDUFA goal date December 27, 2026. 08/06/26:- NDA acceptance reiterated; PDUFA remains December 27, 2026.
Verification
Confirm timing and program details against the company announcement or filing.