Catalyst overview
Research summary
This catalyst tracks a Approved update for Icotrokinra (JNJ-2113) (PN-235) in Psoriasis. The expected timing is based on the latest available company guidance and may change.
ICONIC studies. (ICONIC-ADVANCE, ICONIC-ADVANCE 1&2) Collab w/ Janssen. 3/8/25- Topline results from Ph3 ICONIC-ADVANCE 1&2studies. 4/10/25- New data from subgroup analysis of ICONIC-LEAD and presentation at WCPD. 5/9/25- ICONIC-TOTAL trial results reported. 7/21/25- NDA submitted. 9/18/25- Presentation at EADV. 10/27/25- 52-wk data presented. 11/06/25:- ICONIC-LEAD and ICONIC-TOTAL psoriasis results published in the New England Journal of Medicine and NEJM Evidence. Long-term 52-week data from ICONIC-TOTAL showed durable clearance in difficult-to-treat skin areas; NDA and EMA submissions for psoriasis reiterated with no new regulatory timelines. 02/25/26:- U.S. regulatory decision for ICOTYDE anticipated in 2026; ICONIC-ASCEND psoriasis Phase 3 primary endpoint enrollment completion also expected 2026. 03/18/26:- FDA approved ICOTYDE for plaque psoriasis; $50M milestone triggered. Ongoing ICONIC-PsA, ICONIC-UC, ICONIC-CD studies noted. 03/28/26:- One-year Ph3 ICONIC-ADVANCE 1/2 and ICONIC-LEAD AAD 2026 data showed durable clearance; no new safety signals. 05/05/26:- FDA approval and one-year Phase 3 psoriasis data for ICOTYDE reiterated; milestone and royalty terms detailed. 08/05/26:- ICOTYDE recorded first full commercial sales quarter after March 2026 launch.
Verification
Confirm timing and program details against the company announcement or filing.