Bezuclastinib (CGT9486) (KIT exon 17 inhibitor)

Development notes

SUMMIT trial. 2/22/24- Initiated Part 2. 2/27/25- Reported expanded clinical results from OLE portion of SUMMIT. Data presented AAAAI/WAO'25. 7/7/25- Announced favorable topline results. NDA submission by YE 2025. 10/20/25- Granted Breakthrough Therapy Designation. 11/3/25- Presentations at ASH'25 on Dec 6-9, 2025. 11/03/25:- Pre-NDA FDA alignment for broad NonAdvSM; BTD reiterated; NDA submission remains on track for YE 2025. 12/06/25:- SUMMIT Part 2 complete; 48-week efficacy and safety positive; NDA submission planned December 2025; long-term follow-up data Q1 2026. 12/30/25:- NDA submitted to FDA for NonAdvSM based on positive SUMMIT pivotal data. 01/12/26:- FDA NDA acceptance for NonAdvSM expected by end February 2026; detailed SUMMIT trial data presentations planned in H1 2026. 02/10/26:- Multiple SUMMIT NonAdvSM bezuclastinib posters at AAAAI 2026 on Feb 28; NDA submission in Dec 2025 reiterated. 02/17/26:- SUMMIT NDA submitted December; FDA acceptance expected February 2026; six AAAAI 2026 abstracts and SM expanded access programs planned. 02/28/26:- Additional SUMMIT NonAdvSM posters at AAAAI showed deeper 48-week symptom and tryptase improvements plus bone density gains. 03/16/26:- FDA accepted NonAdvSM NDA; PDUFA December 30, 2026; no AdCom planned. 05/05/26:- NonAdvSM NDA acceptance with December 30, 2026 PDUFA and AAAAI 2026 poster presentations reiterated. 08/10/26:- SUMMIT switch extension enrolled. Preliminary data by end-2026. PDUFA is December 30, 2026.