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About Cogent Biosciences Inc.
Cogent Biosciences Inc. (NASDAQ: COGT) is a biotechnology company dedicated to developing precision therapies for genetically defined diseases. Headquartered in Waltham, Massachusetts, and Boulder, Colorado, the company leverages advanced scientific research to design targeted treatments that address the underlying genetic causes of serious diseases. Its mission is to improve the lives of patients by delivering innovative therapies that offer both efficacy and safety.
Core Focus: Precision Therapies for Genetically Defined Diseases
Cogent Biosciences' primary focus is on diseases driven by specific genetic mutations. The company’s flagship program, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other KIT exon 17 mutations. These genetic abnormalities are responsible for driving conditions such as systemic mastocytosis (SM), a rare and debilitating disease caused by the uncontrolled proliferation of mast cells, and gastrointestinal stromal tumors (GIST), a type of cancer heavily reliant on oncogenic KIT signaling.
Bezuclastinib: A Transformative Therapy
Bezuclastinib represents a significant advancement in precision medicine. Unlike existing treatments, it is designed to be non-brain-penetrant, reducing the risk of central nervous system (CNS)-related side effects. The drug is currently being evaluated in multiple clinical trials:
- SUMMIT Trial: A Phase 2 trial targeting nonadvanced systemic mastocytosis (NonAdvSM). Early data indicate rapid and sustained symptom improvement, with a favorable safety profile.
- APEX Trial: Focused on advanced systemic mastocytosis (AdvSM), this trial aims to evaluate the safety and efficacy of bezuclastinib in patients with aggressive disease subtypes.
- PEAK Trial: A Phase 3 study assessing the combination of bezuclastinib and sunitinib for second-line treatment of GIST patients.
These trials underscore Cogent's commitment to addressing unmet medical needs in rare and challenging diseases.
Diversified Pipeline
Beyond bezuclastinib, Cogent is advancing a pipeline of novel targeted therapies aimed at addressing other genetically driven diseases. These include:
- FGFR2 Inhibitor (CGT4859): Currently in Phase 1 trials, this therapy targets FGFR2 mutations linked to certain cancers.
- PI3Kα Inhibitor: A potential best-in-class, wild-type-sparing inhibitor designed to treat cancers driven by the H1047R mutation.
- KRAS(ON) Inhibitor: A preclinical program targeting prevalent KRAS mutations in colorectal, lung, and pancreatic cancers.
- ErbB2 Inhibitor: Focused on HER2-driven cancers, this program is in the preclinical stage.
Competitive Landscape and Market Position
Cogent operates in the highly competitive biotechnology sector, where innovation and precision are key differentiators. The company’s focus on genetically defined diseases aligns with the industry’s shift toward personalized medicine. By addressing safety concerns and targeting areas of high unmet need, Cogent positions itself as a leader in precision therapies. Its non-brain-penetrant approach to tyrosine kinase inhibition further distinguishes it from competitors.
Commitment to Patients and Innovation
Cogent Biosciences is not only advancing therapeutic options but also enhancing patient outcomes. The company collaborates with leading academic institutions, advocacy groups, and global clinical sites to ensure its therapies reach those in need. With a strong financial position and a robust clinical pipeline, Cogent is poised to transition into a commercial-stage company, bringing transformative therapies to market.
Conclusion
Cogent Biosciences exemplifies the potential of precision medicine to address complex genetic diseases. Through its innovative therapies and patient-centric approach, the company is making significant strides in improving the standard of care for systemic mastocytosis, GIST, and other genetically defined conditions.
Cogent Biosciences (NASDAQ: COGT) announced four preclinical poster presentations at the upcoming 2025 AACR Annual Meeting in Chicago, scheduled for April 25-30, 2025. The presentations showcase the company's advancement in precision therapies:
- A potent KRAS (ON) inhibitor with selective mutation targeting
- CGT6297: A novel PI3Kα H1047R mutant-selective inhibitor
- CGT4859: A reversible and selective FGFR2/3 inhibitor addressing resistance mutations
- CGT4255: An EGFR sparing, pan-mutant HER2 candidate with potential brain penetration capabilities
Additionally, the company granted an inducement equity award to a new employee, consisting of options to purchase 9,700 shares with a 4-year vesting schedule, approved under Nasdaq Listing Rule 5635(c)(4).
Cogent Biosciences (Nasdaq: COGT) has announced its upcoming participation in a fireside chat at the Leerink Healthcare Conference scheduled for March 12, 2025, at 10:00 a.m. ET. The event will be accessible via webcast on the company's Investors & Media webpage, with replay available for 30 days.
Additionally, the company disclosed an inducement equity grant approved by its Compensation Committee on March 4, 2025. Under Nasdaq Listing Rule 5635(c)(4), a new employee received options to purchase 90,000 shares of Cogent common stock. The option features a 10-year term, with a 4-year vesting schedule: 25% vesting after one year and the remainder vesting monthly over 36 months, contingent on continued employment.
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.
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