Cogent Submits NDA for Bezuclastinib in NonAdvanced Systemic Mastocytosis
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 30 2025
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Source: Globenewswire
- NDA Submission: Cogent Biosciences has submitted its New Drug Application for bezuclastinib targeting NonAdvanced Systemic Mastocytosis to the FDA, based on positive clinical data from the SUMMIT pivotal trial, marking a significant advancement in the precision therapy landscape.
- Clinical Trial Results: The SUMMIT trial demonstrated statistical significance across all primary and key secondary endpoints, with updated data through 48 weeks showing sustained symptomatic improvement, indicating the potential for long-term clinical benefits of the drug.
- Breakthrough Therapy Designation: Bezuclastinib received Breakthrough Therapy Designation from the FDA in October 2025, reflecting its potential to address significant unmet medical needs and enhancing the company's competitive position in the market.
- Future Plans: Cogent plans to submit two additional NDAs for bezuclastinib in Gastrointestinal Stromal Tumors and Advanced Systemic Mastocytosis in the first half of 2026, based on strong results from the PEAK and APEX clinical trials, showcasing the company's ongoing development potential in oncology.
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Analyst Views on COGT
Wall Street analysts forecast COGT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for COGT is 48.70 USD with a low forecast of 34.00 USD and a high forecast of 67.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
11 Analyst Rating
9 Buy
2 Hold
0 Sell
Strong Buy
Current: 38.360
Low
34.00
Averages
48.70
High
67.00
Current: 38.360
Low
34.00
Averages
48.70
High
67.00
About COGT
Cogent Biosciences, Inc. is a biotechnology company. The Company is focused on developing precision therapies for genetically defined diseases. The Company’s clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. In addition to bezuclastinib, the Company is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2 and PI3Kα. SUMMIT is its randomized, global, multicenter, double-blind, placebo-controlled, multi-part Phase II clinical trial for patients with Non-AdvSM. APEX is an open-label, global, multicenter study evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Cogent Biosciences Receives FDA Breakthrough Therapy Designation
- Breakthrough Therapy Designation: The FDA granted Cogent Biosciences Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib for Gastrointestinal Stromal Tumors, marking a significant advancement in cancer treatment.
- Clinical Trial Results: The PEAK trial demonstrated a median progression-free survival of 16.5 months for the bezuclastinib combination compared to 9.2 months for sunitinib monotherapy, reducing the risk of disease progression or death by 50%, indicating substantial clinical benefits.
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