Welcome to our dedicated page for Cogent Biosciences news (Ticker: COGT), a resource for investors and traders seeking the latest updates and insights on Cogent Biosciences stock.
Cogent Biosciences Inc. (NASDAQ: COGT) is a clinical-stage biotechnology company pioneering precision therapies for patients with genetically defined diseases. This dedicated news hub provides investors and researchers with essential updates on the company's innovative programs targeting systemic mastocytosis, GIST, and other mutation-driven conditions.
Access real-time information about bezuclastinib clinical trials, including the SUMMIT (NonAdvSM), APEX (AdvSM), and PEAK (GIST) studies. Stay informed on pipeline developments across Cogent's portfolio of selective kinase inhibitors, from FGFR2-targeted therapies to novel KRAS(ON) inhibitors in preclinical testing.
Our curated news collection features official press releases, regulatory filings, and scientific presentation updates. Key content categories include clinical trial milestones, research collaborations, and therapeutic development progress – all critical for understanding Cogent's position in the precision medicine landscape.
Bookmark this page for streamlined access to verified COGT updates. Investors can monitor the company's advancement of potentially transformative therapies while researchers track developments in mutation-specific treatment approaches.
Cogent Biosciences (NASDAQ: COGT) has reported expanded clinical results from the Open Label Extension (OLE) portion of SUMMIT trial, evaluating bezuclastinib in nonadvanced systemic mastocytosis patients. The data, presented at AAAAI/WAO 2025, showed remarkable improvements after 48 weeks of treatment:
Key findings include:
- 65% mean improvement in Total Symptom Score (TSS)
- 88% of patients achieved >50% TSS reduction
- 94% of patients exceeded 30% TSS reduction
- 63% reduction in most severe symptoms
The trial involved patients with median age 52 years (range 36-76). Safety data from August 2024 showed mostly low-grade, reversible adverse events, primarily hair discoloration and transaminase elevations. The median treatment duration was 56 weeks for the active arm and 40 weeks for placebo crossover patients. Top-line results from SUMMIT Part 2 registration-directed trial are expected in July 2025.
Cogent Biosciences (NASDAQ: COGT) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical trials for bezuclastinib. The company expects top-line results from three pivotal trials in 2025: SUMMIT trial (NonAdvSM) in July, APEX trial (AdvSM) in 2H, and PEAK trial (GIST) by year-end.
Clinical highlights include impressive data from the SUMMIT trial showing 56% mean improvement in Total Symptom Score and 89% of patients with >50% decrease in serum tryptase levels. The APEX trial demonstrated 52% overall response rate per mIWG criteria, rising to 83% for patients receiving 100mg BID.
Cogent's pipeline expansion includes a selective KRAS inhibitor (CGT6737) and PI3Kα inhibitor (CGT6297). The company plans to submit IND applications in 2025 for CGT4255 (ErbB2 inhibitor) and CGT6297.
Financially, Cogent reported $287.1 million in cash and equivalents as of December 31, 2024, plus $25 million from an ATM offering in February 2025. This funding is expected to sustain operations into late 2026, well past planned clinical readouts. R&D expenses increased to $232.7 million for 2024, up from $173.8 million in 2023, while net loss widened to $255.9 million from $192.4 million.
Cogent Biosciences (Nasdaq: COGT) has announced an upcoming poster presentation featuring bezuclastinib at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) in San Diego. The presentation will focus on a subgroup of patients who received 100mg bezuclastinib for at least 48 weeks in the ongoing Summit Trial, highlighting long-term symptomatic benefits.
The poster, titled 'Efficacy and Safety Results of Adult Patients with NonAdvanced Systemic Mastocytosis Receiving Bezuclastinib 100 mg in the Ongoing Summit Trial: A Randomized, Double-Blind, Placebo Controlled Phase 2 Clinical Trial of Bezuclastinib,' will be presented on March 1, 2025, from 9:45-10:45am PT at the San Diego Convention Center.
Cogent Biosciences (Nasdaq: COGT), a biotechnology company specializing in precision therapies for genetically defined diseases, has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company will engage in a fireside chat scheduled for Wednesday, February 5, 2025 at 9:30 a.m. ET in New York.
Interested parties can access a live webcast of the presentation through the Investors & Media section of Cogent's website. The presentation recording will be made available approximately two hours after the event and will remain accessible for 30 days on the company's investor relations platform.
Cogent Biosciences (NASDAQ: COGT) has announced key milestones for 2025, focusing on their lead drug bezuclastinib and other pipeline developments. The company plans to report top-line results from three major clinical trials: the SUMMIT trial for Non-Advanced Systemic Mastocytosis in July, the APEX trial for Advanced Systemic Mastocytosis in H2, and the Phase 3 PEAK trial for second-line GIST by year-end.
The company aims to submit its first New Drug Application (NDA) by the end of 2025. Additionally, Cogent will initiate Expanded Access Programs for SM and GIST patients in Q1 2025. The company is also advancing other pipeline products, including the ongoing Phase 1 trial of CGT4859 (FGFR2 inhibitor) and plans to submit IND applications for their ErbB2 inhibitor (CGT4255) and PI3Kα inhibitor (CGT6737).
Cogent Biosciences (Nasdaq: COGT), a biotechnology company specializing in precision therapies for genetically defined diseases, announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. Andrew Robbins, President and CEO, will deliver a presentation on Tuesday, January 14, 2025, at 7:30 a.m. PT/10:30 a.m. ET. The presentation will be accessible via live webcast on the company's Investors & Media webpage, with a replay available for 30 days following the event.
Cogent Biosciences (NASDAQ: COGT) announced updated clinical results from the SUMMIT trial's Open Label Extension (OLE) evaluating bezuclastinib in nonadvanced systemic mastocytosis patients. The data showed significant improvements with 56% mean improvement in Total Symptom Score at 24 weeks, and 76% of patients achieving at least 50% reduction in symptoms.
The study demonstrated rapid pharmacodynamic response with 89% of patients showing >50% decrease in serum tryptase by week 4, and 95% achieving tryptase levels below 20 ng/ml by week 24. The safety profile was favorable with mostly low-grade, reversible adverse events.
SUMMIT Part 2 enrollment completed ahead of schedule with 179 patients enrolled, with top-line results expected in July 2025.
Cogent Biosciences (NASDAQ: COGT) announced positive updated data from Part 1 of its Phase 2 APEX trial evaluating bezuclastinib in advanced systemic mastocytosis (AdvSM) patients. The trial demonstrated a 52% overall response rate (ORR) per mIWG criteria, with an impressive 83% ORR for patients receiving 100 mg BID dosing.
Key highlights include a median time to response of 2.2 months, with median duration of response and progression-free survival not yet reached. The study involved 32 patients across four dose levels, showing strong efficacy with 94% of patients achieving ≥50% reduction in serum tryptase levels. The drug demonstrated a differentiated safety profile, with mainly low-grade and reversible hematological adverse events.
Top-line data from APEX Part 2 remains on track for mid-2025.
Cogent Biosciences reported significant progress in its pipeline and financial results for Q3 2024. Key highlights include:
- Completion of enrollment in the Phase 3 PEAK trial for GIST patients with 413 participants.
- Acceleration of enrollment in the SUMMIT trial for NonAdvSM and initiation of a Phase 1 trial for FGFR2 inhibitor CGT-4859.
- Strong cash position of $346 million, sufficient to fund operations into late 2026.
Financially, Cogent reported R&D expenses of $63.6 million, G&A expenses of $11.8 million, and a net loss of $70.6 million for Q3 2024. Upcoming milestones include top-line results from the PEAK, SUMMIT, and APEX trials in 2025.
Cogent Biosciences (NASDAQ: COGT) announced two presentations featuring bezuclastinib at the 66th Annual ASH Meeting in December 2024. The presentations will cover long-term follow-up data from two clinical trials: the APEX trial for Advanced Systemic Mastocytosis (AdvSM) and the SUMMIT trial for Nonadvanced Systemic Mastocytosis (NonAdvSM). Dr. Daniel DeAngelo from Dana-Farber Cancer Institute will present APEX data on December 8, while Dr. Lindsay Rein from Duke University will present SUMMIT data on December 9. The company will host an investor webcast on December 9 to review both presentations.
FAQ
What is the current stock price of Cogent Biosciences (COGT)?
What is the market cap of Cogent Biosciences (COGT)?
