Cogent Biosciences Receives FDA Acceptance for New Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
0mins
Cogent Biosciences announced that the U.S. Food and Drug Administration, FDA, has agreed to accept its New Drug Application, NDA, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors, GIST, who have received prior treatment with imatinib under the Real-Time Oncology Review, RTOR, program. "This milestone reflects the FDA's recognition of the significant unmet need facing patients with imatinib resistant GIST," said Andrew Robbins, Cogent's President and Chief Executive Officer. "Based on positive results from the PEAK trial, the bezuclastinib combination has the potential to be the first new approval in this patient population in over 20 years. We look forward to the continued, close collaboration with the FDA as we advance bezuclastinib toward commercialization."
Discover Tomorrow's Bullish Stocks Today
Receive free daily stock recommendations and professional analysis to optimize your portfolio's potential.
Sign up now to unlock expert insights and stay one step ahead of the market trends.
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.
Pfizer Shares Rise on Upgraded Price Forecast
- Forecast Upgrade: Cantor Fitzgerald raised Pfizer's price forecast from $24 to $27, providing a positive catalyst for the pharmaceutical giant despite a 1.6% decline in the broader healthcare sector.
- Licensing Agreement: Pfizer entered a non-exclusive licensing agreement with Novavax for its Matrix-M adjuvant technology, granting Novavax a $30 million upfront payment and potential milestones up to $500 million, indicating Pfizer's proactive approach in product development.
- FDA Breakthrough Therapy: Pfizer's Sutent, in combination with Cogent Biosciences' bezuclastinib, received FDA Breakthrough Therapy Designation after showing a 50% reduction in disease progression risk, enhancing Pfizer's competitive edge in oncology treatments.
- Leadership Warning: At the World Economic Forum, CEO Albert Bourla warned that reduced funding for U.S. universities has weakened America's position in global health research, highlighting China's dominance in health research rankings.
Continue Reading
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.
- NDA Progress: The FDA agreed to accept Cogent's New Drug Application for the bezuclastinib and sunitinib combination under the Real-Time Oncology Review program, with submission completion expected in April 2026, accelerating the drug's path to market.
- Future Trial Plans: Cogent plans to initiate a Phase 2 trial for first-line GIST patients in mid-2026, showcasing the company's ongoing investment in cancer treatment research and market expansion potential.
Continue Reading