Cogent Biosciences advances bezuclastinib with key trial readouts in Systemic Mastocytosis and GIST, plans first NDA filing, and expands pipeline with multiple candidates.

The FDA has received a new drug application seeking the approval of bezuclastinib for the treatment of patients with non-advanced systemic mastocytosis.

Cogent Biosciences (NASDAQ: COGT) outlined key 2026 commercial and clinical milestones for bezuclastinib and its precision therapies pipeline.Planned regulatory and clinical milestones include NDA acceptance for NonAdvSM by end-February 2026, an NDA submission for GIST in April 2026, an NDA submission for AdvSM in 1H 2026, and presentations of pivotal trial data (SUMMIT, PEAK, APEX) at major medical meetings in 1H 2026. The company targets a commercial launch of bezuclastinib in 2H 2026 if approved. Pipeline actions include IND submissions in 2026 for a pan-KRAS(ON) inhibitor and a selective JAK2 V617F inhibitor. Cogent reported a cash balance of ~ $900 million entering 2026 and noted active expanded access programs and a new SVP, Sales hire.

Cogent Biosciences to showcase 48-week bezuclastinib efficacy data from Summit Trial in NonAdvSM patients at prestigious AAAAI 2025 conference in San Diego.

Cogent Biosciences announces FDA Breakthrough Therapy Designation for bezuclastinib, a promising treatment for NonAdvanced Systemic Mastocytosis with NDA submission planned by year-end 2025.

Cogent Biosciences (Nasdaq: COGT) reported positive Phase 3 PEAK results for bezuclastinib + sunitinib in imatinib-resistant or intolerant GIST on Nov 10, 2025. The combination achieved mPFS 16.5 months vs 9.2 months for sunitinib (HR=0.50; 95% CI: 0.39–0.65; p<0.0001) and ORR 46% vs 26% (p<0.0001). Safety was generally tolerable; no new combination-specific risks identified. Cogent plans an NDA submission in 1H 2026, will present full PEAK data at a scientific conference in 1H 2026, and is hosting an investor webcast Nov 10, 2025 at 8:00 a.m. ET.

Cogent Biosciences (Nasdaq: COGT) announced FDA agreement to accept its NDA for bezuclastinib + sunitinib for imatinib‑resistant GIST under the Real‑Time Oncology Review (RTOR) program. The Phase 3 PEAK trial showed a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65), mPFS 16.5 months vs 9.2 months, and ORR 46% vs 26% versus sunitinib. Cogent will initiate RTOR immediately and expects to complete the NDA submission in April 2026. Full PEAK results will be presented in H1 2026 and a Phase 2 first‑line exon 9 trial is planned for mid‑2026.

Bezuclastinib normalized key bone marrow pathology in nonadvanced systemic mastocytosis.

Bezuclastinib markedly improved symptoms and disease markers in nonadvanced systemic mastocytosis, showing durable benefit and a manageable safety profile.

Bezuclastinib shows positive PEAK Phase 3 results in advanced GIST, demonstrating strong activity against KIT exon 17/18 mutations.

Cogent Biosciences (NASDAQ: COGT) reported positive top-line results from the APEX Part 2 trial of bezuclastinib in advanced systemic mastocytosis (AdvSM) on Dec 8, 2025. Key outcomes: 57% ORR per mIWG criteria and 80% ORR per PPR; 89% of patients achieved ≥50% reductions in bone marrow mast cells and in serum tryptase; 91% achieved ≥50% reduction in KIT D816V VAF (n=43). Median time to response was 2.0 months; median duration of response is not yet mature. Safety: no discontinuations due to treatment-related adverse events and 14.8% required dose reductions. Cogent expects an NDA submission in 1H 2026 and will present detailed data in 1H 2026.

Cogent Biosciences announced "transformative" success with their experimental drug, bezuclastinib, in combination with sunitinib, significantly delaying disease progression in patients battling advanc...

Cogent Biosciences, Inc. (Nasdaq: COGT) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclas

Cogent Biosciences (Nasdaq: COGT) announced that the FDA granted Breakthrough Therapy Designation for bezuclastinib combined with sunitinib for patients with GIST after prior imatinib. The designation is based on PEAK trial results showing a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65) and mPFS of 16.5 months vs. 9.2 months for sunitinib alone. The combination showed no new safety risks versus known sunitinib profile. Cogent is on track to complete its PEAK NDA submission under RTOR in April 2026, plans a PEAK full-data presentation in H1 2026, and expects a mid-2026 Phase 2 trial for first-line exon 9 GIST patients.

Cogent Biosciences (Nasdaq: COGT) announced the FDA granted Breakthrough Therapy Designation for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) previously treated with avapritinib and in Smoldering Systemic Mastocytosis.The designation is based on positive SUMMIT results showing statistical significance across all primary and key secondary endpoints; top-line SUMMIT data were reported in July 2025 and additional data will be presented at a scientific conference. Cogent completed a pre-NDA meeting and plans an NDA submission by year-end 2025, with Breakthrough benefits including Priority Review eligibility and rolling submissions.Cogent also plans top-line reads for the Phase 3 PEAK trial in GIST in November 2025 and for the APEX trial in AdvSM in December 2025.