CGT1815 / Cogent Biosci - LARVOL DELTA

Anticipated Upcoming Milestones (Cogent Biosciences Press Release) - "(i) Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor; (ii) Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor."

IND • JAK2V617F • Trial status • Oncology • Solid Tumor

Upcoming Milestones (Cogent Biosciences Press Release) - "Submit the APEX NDA in the first half of 2026 for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM)...Initiate a Phase 2 trial in the first half of 2026 investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib....Pending FDA approval(s), launch bezuclastinib in the second half of 2026....Submit Investigational New Drug (IND) applications for CGT1815....Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor"

FDA filing • IND • Launch US • New P2 trial • Trial status • Breast Cancer • Gastrointestinal Stromal Tumor • HER2 Breast Cancer • Non Small Cell Lung Cancer • Oncology • Rare Diseases

Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones… (GlobeNewswire) - "Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor; Present clinical data on CGT4859, Cogent’s selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study in patients with alterations in FGFR2 or FGFR3; Complete dose escalation for both CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor, and CGT6297, Cogent’s selective PI3Kα inhibitor."

IND • JAK2V617F • P1/2 data • Trial status • Breast Cancer • Cholangiocarcinoma • Lung Cancer