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Cogent Biosciences, Inc. (NASDAQ: COGT) is a pioneering biotechnology company focused on developing precision therapies for genetically defined diseases. Headquartered in Waltham, MA, and Boulder, CO, Cogent's mission is to design rational, targeted therapies that treat the underlying causes of disease, thereby improving the lives of patients. The company's lead program, bezuclastinib, is a selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other mutations in KIT exon 17. This mutation is a key driver of Systemic Mastocytosis (SM) and Advanced Gastrointestinal Stromal Tumors (GIST), both serious diseases dependent on oncogenic KIT signaling.
Bezuclastinib is undergoing rigorous clinical trials, with the PEAK, SUMMIT, and APEX trials all targeted toward specific genetic mutations associated with these diseases. The company has made significant strides in 2024, including the initiation of a new Phase 2 clinical trial of bezuclastinib in later line GIST patients in collaboration with the Sarcoma Alliance for Research through Collaboration (SARC), The Life Raft Group, and Dana-Farber Cancer Institute.
In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies focused on mutations in FGFR2, ErbB2, and PI3Kα. These programs aim to create therapies with potential best-in-class properties, targeting rare and genetically driven diseases.
The company recently secured $225 million in a private investment led by prominent investors, ensuring a robust financial position that supports its ambitious research and development goals. Cogent's financial stability is further reinforced by a strong cash runway projected to extend into 2027, allowing the company to complete its ongoing and planned clinical trials.
Latest News:
- February 26, 2024: Cogent announces a successful $225 million funding round, enhancing its financial stability.
- February 22, 2024: Positive Part 1b data from the ongoing SUMMIT trial evaluating bezuclastinib in NonAdvSM patients.
- February 14, 2024: New Phase 2 clinical trial of bezuclastinib in later line GIST patients announced in collaboration with SARC.
- January 9, 2024: Key milestones for 2024 highlighted at J.P. Morgan’s 42nd Annual Healthcare Conference.
For more detailed and updated information, visit Cogent Biosciences' official website and follow them on social media platforms like X (formerly known as Twitter) and LinkedIn.
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.
Cogent Biosciences announced the expansion of its pipeline with a new KRAS inhibitor program and presented preclinical data at the 2024 EORTC-NCI-AACR Symposium. The company showcased two programs: CGT6737, a pan KRAS(ON) inhibitor with selectivity over HRAS and NRAS, demonstrating 90% PD inhibition in mouse models, and CGT6297, a PI3Kα inhibitor targeting H1047R mutations affecting over 55,000 cancer patients annually. CGT6297 showed 25-fold selectivity over PI3Kα WT with superior efficacy compared to approved therapies. IND-enabling studies for CGT6297 are planned for 2025.
Cogent Biosciences (Nasdaq: COGT) has announced significant progress in its clinical trials for bezuclastinib, a potential best-in-class KIT mutant inhibitor. The Phase 3 PEAK trial for gastrointestinal stromal tumors (GIST) has completed enrollment with 413 patients, exceeding the target. The trial has also advanced past the interim futility analysis with no modifications recommended. Additionally, the SUMMIT trial for nonadvanced systemic mastocytosis (NonAdvSM) is now expected to complete enrollment in Q1 2025, earlier than initially projected. Top-line results for both trials are anticipated in the second half of 2025. The company also announced the appointment of Darara Dibabu as Vice President of Marketing.
Cogent Biosciences (Nasdaq: COGT) reported Q2 2024 financial results and business highlights. Key points include:
1. Enrollment in SUMMIT, PEAK, and APEX registration-directed trials remains on track, with topline results expected in 2025.
2. Q2 2024 ended with $390 million cash, funding operations into 2027.
3. Positive data from SUMMIT Part 1 and PEAK trials presented at EHA and ASCO.
4. New Phase 2 trial of bezuclastinib plus sunitinib in later-line GIST patients announced.
5. Q2 2024 R&D expenses increased to $54.3 million, up from $38.9 million in Q2 2023.
6. Net loss for Q2 2024 was $59.0 million, compared to $44.1 million in Q2 2023.
Cogent Biosciences announced a positive alignment with the FDA on their novel patient-reported outcome measure, MS2D2, for the SUMMIT trial targeting Nonadvanced Systemic Mastocytosis (NonAdvSM). The MS2D2 questionnaire will be used to assess symptom severity and changes in NonAdvSM patients throughout the trial, focusing on the eleven most frequent and severe symptoms. The enrollment for SUMMIT Part 2 is expected to complete by Q2 2025, with top-line results due by the end of 2025.
Additionally, Cogent aims to complete enrollment in the APEX study for Advanced Systemic Mastocytosis (AdvSM) by the end of 2024, with results expected by mid-2025. The PEAK study focusing on second-line Gastrointestinal Stromal Tumors (GIST) patients is also progressing well, with enrollment expected to finish by Q3 2024 and results anticipated by late 2025.
Cogent Biosciences announced new data from Part 1 of its SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).
The data, presented at the 2024 European Hematology Association Congress, showcased significant reductions in severe symptoms and mast cell reactions for patients treated with 100 mg of bezuclastinib.
Key findings included >90% reductions in mast cell burden, >50% reductions in mast cell reactions, and improvements in skin lesions. The drug demonstrated a favorable safety profile with no serious adverse events.
Enrollment for SUMMIT Part 2 and other key studies is ongoing, with results expected between mid-2024 and year-end 2025.
Cogent Biosciences has named Cole Pinnow as Chief Commercial Officer, effective May 23, 2024. Pinnow brings 25 years of biopharmaceutical industry experience, including roles at Pfizer where he led a $5B cancer portfolio. At Cogent, Pinnow will oversee the commercial strategy for the anticipated launch of bezuclastinib, aimed at treating systemic mastocytosis (SM) and Gastrointestinal Stromal Tumors (GIST).
His appointment includes inducement equity awards of 525,000 stock options and up to 214,000 performance-based restricted stock units, encouraging long-term company growth. CEO Andrew Robbins highlighted Pinnow's expertise as important for transitioning Cogent into a fully integrated commercial organization.
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