Cogent Biosciences
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2014-01-01
- Employees
- 164
- Market Cap
- $1B
- Website
- http://www.cogentbio.com
- Introduction
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.
Atara Biotherapeutics Navigates Regulatory Hurdles and Financial Uncertainty
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• The company's need for additional financing to support its key programs is crucial, but uncertainties around resolving the clinical hold complicate matters.
• Recent workforce reductions, affecting about half of its employees, reflect ongoing challenges following the FDA's Complete Response Letter for EBVALLO.
• Atara is exploring strategic options, including potential mergers or acquisitions, to secure funding amidst regulatory and manufacturing challenges.
Advancements in Gastrointestinal Stromal Tumors Treatment Pipeline
Recent developments in the Gastrointestinal Stromal Tumors (GIST) treatment pipeline highlight significant progress, with over 25 companies actively developing more than 28 pipeline drugs. Key players like Jiangsu Hengrui Medicine, Novartis, and Daiichi Sankyo Company are advancing promising therapies, including Famitinib, Nilotinib, and DS 6157, through various stages of clinical trials.
Cogent Bio Presents Bezuclastinib Data Highlighting Long-Term Benefits in Non-Advanced Systemic Mastocytosis
• 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.
Cogent Biosciences' Bezuclastinib Shows Promise in Systemic Mastocytosis Trials
• Cogent Biosciences reports that bezuclastinib shows a 56% average improvement in Total Symptom Score (TSS) at 24 weeks in non-advanced systemic mastocytosis (NonAdvSM) patients.
• In advanced systemic mastocytosis (AdvSM) patients, bezuclastinib shows a 52% ORR per mIWG criteria, including 83% ORR for patients receiving 100 mg BID.
• The APEX trial of bezuclastinib in AdvSM demonstrates rapid and deep clinical responses with a favorable safety profile, avoiding concerning side effects.
• Cogent anticipates top-line results from the APEX Part 2 study in mid-2025 and has completed enrollment for SUMMIT Part 2 ahead of schedule.
Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2024 Financial Results
Cogent Biosciences has reported significant progress in its clinical trials, including the completion of enrollment in the Phase 3 PEAK trial and the initiation of a Phase 1 trial for CGT-4859. The company also announced a strong cash position of $346 million, sufficient to fund operations into late 2026. Upcoming milestones include the delivery of top-line results from SUMMIT, PEAK, and APEX trials in 2025.
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