Cogent Biosciences, Inc.

Cogent Biosciences announced positive preclinical data for CGT1145, its novel JAK2 V617F mutant-selective inhibitor, at the 2026 European Hematology Association Congress. The data highlights CGT1145's potential best-in-class properties, including over 100x selectivity compared to JAK2 WT and JAK1/3 isoforms, high oral bioavailability, and low clearance. The company remains on track to submit an Investigational New Drug (IND) application for CGT1145 in 2026, aiming to address myeloproliferative neoplasms with improved hematologic tolerability.

Cogent Biosciences announced updated positive clinical results from its APEX trial for bezuclastinib in advanced systemic mastocytosis (AdvSM) patients, showing a 65% objective response rate (ORR) per mIWG criteria and 81% ORR per PPR criteria. The drug also demonstrated significant reductions in mast cell burden and a favorable safety profile. The company plans to submit the New Drug Application (NDA) for bezuclastinib in June 2026 and aims for a launch later this year for both systemic mastocytosis and GIST, following FDA approval.

Cogent Biosciences announced detailed positive clinical data from the PEAK Phase 3 trial of bezuclastinib in combination with sunitinib for GIST patients, demonstrating a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR). The combination achieved a median PFS of 16.5 months compared to 9.2 months for sunitinib alone, with a clear benefit across all mutational subgroups and a well-tolerated safety profile. The company also confirmed FDA Priority Review for the bezuclastinib combination, with a PDUFA date set for November 30, 2026, and initiated a new clinical trial for first-line GIST patients.

Cogent Biosciences announced that the FDA has accepted its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior imatinib treatment. The FDA granted Priority Review with a PDUFA target action date of November 30, 2026, and currently has no plans for an advisory committee. This follows positive Phase 3 PEAK trial results demonstrating a median Progression-Free Survival (PFS) of 16.5 months versus 9.2 months for sunitinib alone, and an Objective Response Rate (ORR) of 46% versus 26%. Full results will be presented at ASCO this weekend.

Cogent Biosciences announced that pivotal data from its APEX trial for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) has been accepted for an oral presentation at the European Hematology Association (EHA) Congress. This marks the company's third oral presentation of pivotal data for bezuclastinib at a major medical meeting. Additionally, preclinical data from its emerging JAK2 V617F program will be presented as a poster at the same congress, highlighting the company's progress in developing precision therapies.

Cogent Biosciences reported a significant increase in its net loss for the first quarter of 2026, reaching $97.4 million, up from $72.0 million in the prior year. This was primarily driven by a rise in operating expenses, including research and development and general and administrative costs. While the company's cash and marketable securities are expected to fund operations for at least the next 12 months, it anticipates needing additional funding for its ongoing clinical development and commercialization efforts, including the planned launch of bezuclastinib in the second half of 2026.

Cogent Biosciences reported its first quarter 2026 financial results and provided significant business updates, highlighting a pivotal year for the company. The FDA accepted its New Drug Application for bezuclastinib in NonAdvanced Systemic Mastocytosis, setting a PDUFA target action date of December 30, 2026, and the company also submitted an NDA for bezuclastinib in GIST under the FDA's Real-Time Oncology Review program. Financially, Cogent ended Q1 2026 with a strong cash position of $866.4 million, projected to fund operations into 2028, despite an increased net loss of $97.4 million for the quarter. The company is preparing for potential dual launches of bezuclastinib in Systemic Mastocytosis and GIST in the second half of 2026.

Cogent Biosciences announced plans for dual launches of bezuclastinib in Systemic Mastocytosis and GIST, highlighting a pivotal year with two NDAs under FDA review and a third expected in the first half of 2026. The company reported a strong cash position of $866.4 million at the end of Q1 2026, providing a runway into 2028. Q1 2026 saw an increased net loss of $97.4 million, driven by higher R&D and G&A expenses as the company advances its pipeline and prepares for commercial launches.

Cogent Biosciences announced the presentation of preclinical data for two pipeline programs, CGT1263 and CGT4255, at the American Association for Cancer Research (AACR) Annual Meeting 2026. The data for CGT1263, a novel pan-KRAS(ON) inhibitor, highlighted its best-in-class cellular potency and kinase selectivity, suggesting a potential reduction in skin toxicity compared to current multi-RAS inhibitors. Separately, CGT4255, a selective ErbB2 inhibitor, demonstrated best-in-class CNS penetrant properties and synergistic activity when combined with HER2 ADCs, addressing unmet needs for HER2+ patients with brain metastases and resistance.