Hidradenitis suppurativa, Generalized pustular psoriasis, EGFRi-mediated skin toxicity, Ichthyosis, Palmoplantar pustulosis, Acne
ANABAnaptyBio IncCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Imsidolimab (ANB019) (anti-IL-36R) in Hidradenitis suppurativa, Generalized pustular psoriasis, EGFRi-mediated skin toxicity, Ichthyosis, Palmoplantar pustulosis, Acne. The expected timing is based on the latest available company guidance and may change.
HARP Ph2/GEMINI-1, GEMINI-2 Ph3 trials. Ph2 data reported 9/1/22. 10/9/23- Reported topline data from both trials. Present comprehensive data from GEMINI-1 and GEMINI-2 results at a medical meeting in H2 2024. 9/24- Presented Ph3 topline data; effective & well-tolerated. 5/5/25- Outlicensed to VNDA. 8/6/25- BLA submission in H2 2025. 11/04/25:- Vanda expects FDA BLA submission for imsidolimab in GPP in Q4 2025. 12/15/25:- BLA submitted for GPP; priority review requested; potential FDA approval as early as Mid-2026. 02/25/26:- FDA accepted GPP BLA; PDUFA target action date December 12, 2026. 03/03/26:- Company reiterates FDA acceptance of GPP BLA and December 12, 2026 PDUFA target action date. 05/12/26:- Company reiterates FDA PDUFA target action date December 12, 2026 for GPP approval.
Verification
Confirm timing and program details against the company announcement or filing.