| Research | IND-Enabling | Phase 1 | Phase 1/2 | Phase 3 | Regulatory Submission |
Approved |
|---|---|---|---|---|---|---|
Ripretinib
KIT Inhibitor
-
GIST ≥4ᵗʰ Line (INVICTUS Study)⁽¹⁾
-
GIST 2nd Line KIT Exon 11 + 17/18 (INSIGHT Phase 3 Study)⁽²⁾
Vimseltinib
CSF1R Inhibitor
-
TGCT (Phase 3 MOTION Study)⁽³⁾
-
TGCT (Phase 1/2 Study)
-
cGVHD (Phase 2 Study)
DCC-3116
ULK Inhibitor
-
+ KRAS G12C Inhibitor (Sotorasib)
-
+ KIT Inhibitor (Ripretinib)
Updated as of February 2024; (1) Exclusive development and commercialization license with Zai Lab in Greater China for QINLOCK; (2) The patient population for the INSIGHT study consists of second-line GIST patients with mutations in KIT exon 11 and 17 and/or 18 and the absence of mutations in KIT exon 9, 13, and/or 14 (also referred to as KIT exon 11 + 17/18 patients); (3) The Company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vimseltinib for the treatment of patients with TGCT in 2Q 2024 and a Marketing Authorisation Application (MAA) to the European Medicines Agency in 3Q 2024.