Bezuclastinib (CGT9486) (KIT exon 17 inhibitor) + Sunitinib

Development notes

PEAK trial. 9/3/24- Completed enrollment. 11/10/25- Topline results reported: 16.5 months mPFS, 46% ORR. Submit NDA and present full results at conference in H1 2026. 12/08/25:- Company preparing multiple bezuclastinib commercial launches, including GIST, in H2 2026 following positive PEAK, SUMMIT, and APEX trials. 01/12/26:- NDA submission for second-line GIST planned April 2026; updated PEAK trial data presentations expected in H1 2026. 01/20/26:- FDA accepted GIST NDA into RTOR; full PEAK results H1 2026; first-line exon 9 Ph2 starts mid-2026. 01/26/26:- BTD granted for bezuclastinib+sunitinib in post-imatinib GIST; NDA submission April 2026, full PEAK data H1 2026. 02/17/26:- PEAK NDA under RTOR progressing toward April 2026 completion; expanded access program now active for eligible GIST patients. 04/01/26:- Completed PEAK NDA submission under RTOR. Full Phase 3 PEAK results to be presented in H1 2026. 04/21/26:- PEAK primary results to be presented at ASCO May 30, 2026. 05/05/26:- ASCO 2026 May 30 PEAK oral presentation of pivotal Phase 3 GIST data reiterated. 05/28/26:- FDA accepted GIST NDA; PDUFA Nov 30, 2026. PEAK full results at ASCO May 30. 05/30/26:- Detailed PEAK Ph3 data reported; Priority Review confirmed with November 30, 2026 PDUFA for post-imatinib GIST. 08/10/26:- PEAK data reiterated. Mean treatment duration was 21.4 months. PDUFA is November 30, 2026.