Cogent Biosciences, Inc. is a biotechnology company, which engages in the development of precision therapies for genetically defined diseases. It focuses on CGT9486, a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. The company was founded by Charles Wilson and Dario Campana in March 2014 and is headquartered in Waltham, MA.
相关临床试验
25
10 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2014
进行中（未招募）
9
36.0%
Available
2
8.0%
已完成
2
8.0%
尚未招募
1
4.0%
招募中
7
28.0%
终止
4
16.0%
暂无批准数据
- The FDA has accepted Cogent Biosciences' New Drug Application for bezuclastinib in advanced systemic mastocytosis, with a PDUFA target action date of June 29, 2027. - The filing is supported by APEX pivotal trial data showing a 65% overall response rate by mIWG-MRT-ECNM criteria and 81% response by pure pathological response criteria. - Bezuclastinib also demonstrated durable activity with 12-month progression-free survival of 79% and 12-month overall survival of 87%, with median values not yet mature. - Cogent is simultaneously pursuing FDA review of bezuclastinib in non-advanced systemic mastocytosis and GIST, with PDUFA dates of December 30 and November 30, 2026.
- PMV Pharmaceuticals is a clinical-stage biotech focused on precision oncology therapies that modulate the p53 tumor suppressor pathway, frequently altered in solid tumors. - The company's pipeline centers on identifying specific mutations and molecular profiles where p53-targeted drugs could deliver clinical benefit, with early trials focused on safety, dosage, and efficacy signals. - As a small-cap Nasdaq listing with a market capitalization of 68.961 million USD, PMV Pharmaceuticals relies on cash reserves, equity issuance, and partnerships to fund its R&D. - Regulatory interactions with agencies such as the FDA are central to the company's trajectory, with positive feedback potentially enabling accelerated pathways for serious or rare cancers.
- GSK will present first-time data from velzatinib in first-line gastrointestinal stromal tumors (GIST) at ASCO 2026, showing a 61% response rate in 18 patients from the phase Ib StrateGIST 1 study. - The promising early results have accelerated initiation of the StrateGIST Frontline phase III trial, which will compare velzatinib against imatinib (Gleevec) with overall survival as the primary endpoint. - Velzatinib demonstrates broad activity across clinically relevant KIT mutations and substantial circulating tumor DNA clearance, addressing a key unmet need in GIST treatment. - GSK acquired velzatinib through its $1 billion acquisition of IDRx in January 2025, positioning the company to compete with Cogent's bezuclastinib in the KIT inhibitor space.
- OnKure is set to report first substantial human data for OKI-219, an H1047R mutation-specific PI3Kα inhibitor, in the current quarter after raising $65 million in 2024. - Cogent Biosciences has entered the field with CGT6297, making it the second clinical-stage PI3Kα inhibitor specific for the H1047R mutation alongside OnKure's OKI-219. - Lilly previously abandoned its H1047R-specific approach after LOXO-783 showed only 3% response rate, instead acquiring Scorpion's broader mutant-selective inhibitor tersolisib. - Analysts expect OnKure's Faslodx combination to achieve mid-30% response rates with clean safety profile to restore investor confidence in the $38 million valued company.
- Cogent Biosciences successfully priced concurrent public offerings totaling approximately $475.3 million in net proceeds to fund development of bezuclastinib and other precision therapies. - The company's lead candidate bezuclastinib is a selective tyrosine kinase inhibitor designed to target the KIT D816V mutation driving systemic mastocytosis and advanced gastrointestinal stromal tumors. - Proceeds will support bezuclastinib's development and anticipated commercial launch, while also funding the company's broader pipeline targeting genetically defined diseases. - The financing includes $300 million in common stock and $200 million in convertible notes, providing substantial capital runway for the biotechnology company's clinical programs.
- A new Q4 2025 Catalyst Monitor report identifies 20 significant market-moving events expected in the fourth quarter, based on key opinion leader interviews and predictive intelligence. - Major approval decisions are anticipated for Cytokinetics' aficamten for obstructive hypertrophic cardiomyopathy and Aldeyra's reproxalap for keratoconjunctivitis sicca. - GSK's depemokimab faces regulatory decisions for chronic rhinosinusitis and asthma, while ongoing trials include Sanofi's tolebrutinib for primary progressive multiple sclerosis. - The report covers trial initiations, completions, top-line results, regulatory filings, PDUFA dates, and expected approvals across diverse therapeutic areas.
- Cogent Biosciences presented preclinical data for CGT1263, a pan KRAS(ON) inhibitor showing picomolar activity and selectivity over HRAS and NRAS at the 2025 AACR-NCI-EORTC Conference. - The company's prodrug CGT1815 demonstrated superior tumor growth inhibition compared to competitor RMC-6236 in KRAS G12D and G12V studies. - Cogent plans to file an Investigational New Drug application with the FDA in 2026, targeting cancers driven by KRAS mutations including colorectal, lung, and pancreatic cancers.
- Cogent Biosciences' bezuclastinib demonstrated superior symptom improvement with a placebo-adjusted difference of 8.91 points in total symptom score at 24 weeks (p=0.0002) in the SUMMIT trial. - The drug showed remarkable efficacy on mast cell burden, with 87.4% of patients achieving at least 50% reduction in serum tryptase compared to 0% in the placebo group. - Bezuclastinib exhibited a favorable safety profile with most adverse events being low-grade, supporting its potential for chronic use in systemic mastocytosis patients. - The company plans to submit a New Drug Application to the FDA by the end of 2025 based on these positive results from the registration-directed trial.
- Cogent Biosciences secured a $400 million non-dilutive debt financing facility with SLR Capital Partners, with an initial $50 million already drawn to support the company's growth strategy. - The company is on track to report results from three pivotal bezuclastinib trials in 2025, starting with SUMMIT results in July for NonAdvSM patients. - Additional funding tranches are tied to clinical milestones, with $100 million available upon successful SUMMIT and PEAK trial readouts and commercial success. - The financing enhances Cogent's financial flexibility as it prepares for the expected bezuclastinib launch in 2026 for genetically defined diseases.
- Cogent Biosciences will present a poster on bezuclastinib at the AAAAI Annual Meeting, focusing on long-term symptomatic benefits in NonAdvSM patients. - The poster highlights efficacy and safety results from the ongoing SUMMIT trial in adult NonAdvSM patients receiving 100mg of bezuclastinib. - Cogent anticipates top-line results from the SUMMIT trial in July 2025 and plans to submit an NDA for bezuclastinib by the end of 2025. - Expanded Access Programs for bezuclastinib are expected to launch in the U.S. in Q1 2025 for Systemic Mastocytosis and Gastrointestinal Stromal Tumors patients.
