Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for D-PLEX-100 in Surgical site infection. The expected timing is based on the latest available company guidance and may change.
SHIELD II study. 5/14/25- Enrollment completed. 6/9/25- Reported topline results, met primary & secondary endpoints. 10/5/25- Presentation at ACS'25. 12/3/25- Pre-NDA meeting held; FDA agreed to rolling NDA. Initial submission in early 2026. 02/11/26:- FDA confirmed rolling NDA; submission to begin by Q1 2026 end. Advanced U.S. partnership talks ongoing. 03/17/26:- FDA granted PDUFA fee waiver; first rolling NDA sections expected by end of March 2026. 03/31/26:- Submitted CMC and nonclinical NDA modules; clinical section expected in Q2 2026. 04/13/26:- New SHIELD II Ph3 PK data to be presented at ESCMID Global 2026 on Apr 19, 2026. 04/28/26:- Present SHIELD II ASEPSIS analysis at SIS 2026 on May 6, 2026. 05/13/26:- NDA filing initiated March 30; completion imminent. EMA meetings Q2 2026, MAA Q3 2026, PDUFA planned Q1 2027. 06/01/26:- Rolling NDA submission completed. FDA decision anticipated in Q1 2027. 07/29/26:- FDA accepted NDA with Priority Review; PDUFA set for November 28, 2026, about one quarter earlier. 08/12/26:- Azurity partnership achieved $30 million in payments. PDUFA decision will occur November 28, 2026. EMA MAA submission is expected in Q3 2026; U.S. launch is targeted for Early 2027.
Verification
Confirm timing and program details against the company announcement or filing.