Cogent Biosciences Receives FDA Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 26 2026
0mins
Should l Buy COGT?
Cogent Biosciences announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation, BTD, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib. "We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST," said Andrew Robbins, Cogent's President and Chief Executive Officer. "We look forward to the continued collaboration with the FDA as we work to bring the first new treatment option in over twenty years to this patient population."
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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: 35.700
Low
34.00
Averages
48.70
High
67.00
Current: 35.700
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.
Fairmount Funds Management Sells 3.5 Million Shares of Cogent
- Sale Overview: On January 22, 2026, Fairmount Funds Management LLC indirectly sold 3.5 million shares of Cogent at $36.40 per share, generating approximately $127.4 million in transaction value, which represented 38.87% of its total indirect holdings, reducing its stake from 9,003,418 to 5,503,418 shares.
- Stock Surge Context: Cogent's stock skyrocketed over 342% in 2025, and this significant share sale has sparked speculation about management taking profits, although Fairmount's exact motives remain unclear; nonetheless, the over $120 million gain from this transaction is substantial.
- Holding Structure Analysis: Despite the large sale of common shares, Fairmount still holds approximately 67,414 units of Series A Convertible Preferred Stock, which could convert to about 16.85 million common shares, but due to a 9.9% ownership limit, they would need to sell some common shares first to facilitate this conversion.
- Investment Strategy and Market Performance: Fairmount Funds focuses heavily on biotech investments, with Cogent being a key part of its portfolio, showcasing potential in targeted therapies for rare diseases, and combined with its strong market performance, it may present long-term profit opportunities for investors.
See More
Fairmount Funds Sells 3.5 Million Shares of Cogent Biosciences
- Transaction Overview: On January 22, 2026, Fairmount Funds Management LLC indirectly sold 3.5 million shares of Cogent Biosciences for approximately $127.4 million, highlighting its investment strategy in the biotech sector.
- Change in Holdings: This transaction reduced Fairmount's indirect holdings by 38.87%, leaving 5,503,418 shares, which may indicate a potential shift in confidence regarding Cogent's future prospects.
- Market Context Analysis: At the time of the sale, Cogent's shares were priced at $36.40, lower than the closing price of $39.53 that day, suggesting a cautious market sentiment that could impact investor confidence.
- Investor Implications: Although Fairmount still holds about 67,414 units of Series A Convertible Preferred Stock, which could convert to approximately 16.85 million common shares, the 9.9% ownership limit will restrict future sales, affecting liquidity management.
See More
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.
See More
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.
See More
Cogent Biosciences Insider Sells 65,000 Shares for $2.52 Million
- Insider Sale: Evan Kearns, Chief Legal Officer of Cogent Biosciences, sold 65,000 shares on December 26 for a total of $2.52 million at a weighted average price of $38.70, reducing his direct holdings by 37.27%, indicating a cautious outlook on the company's future.
- Ownership Change: Following this transaction, Kearns's direct ownership stands at 109,398 shares, and this sale marks his only open-market transaction, with no derivatives or indirect holdings involved, maintaining his direct control over the company.
- Market Reaction: Kearns's sale did not trigger panic in the market, as it occurred after a significant stock price surge due to the company's public offering and clinical advancements, suggesting a normal liquidity management strategy at high valuations.
- Strategic Context: Cogent focuses on precision therapies for rare diseases, and Kearns's sale does not undermine the company's long-term strategy in oncology and rare disease markets, with future value hinging on clinical execution and regulatory progress.
See More
Cogent Biosciences' CLO Sells 65,000 Shares for $2.52 Million
- Reduction in Holdings: Evan Kearns, the Chief Legal Officer of Cogent Biosciences, sold 65,000 shares for $2.52 million, reducing his direct ownership by 37.27% to 109,398 shares, significantly lowering his direct exposure to the company's equity.
- Market Reaction: This transaction occurred after Cogent's stock surged following a public offering announcement in November, reflecting strong momentum in financing and clinical progress, although Kearns' sale may trigger short-term market fluctuations.
- Transaction Context: Kearns' sale is the only recorded open-market transaction, with all shares sold being directly held, indicating no involvement of derivatives or indirect interests, suggesting sustained confidence in the company's future.
- Investor Focus: While Kearns' sale may be viewed as insider liquidity, Cogent's long-term value will ultimately hinge on clinical execution and regulatory advancements rather than a single sale event.
See More
Fairmount Funds Management Sells 3.5 Million Shares of Cogent
- Sale Overview: On January 22, 2026, Fairmount Funds Management LLC indirectly sold 3.5 million shares of Cogent at $36.40 per share, generating approximately $127.4 million in transaction value, which represented 38.87% of its total indirect holdings, reducing its stake from 9,003,418 to 5,503,418 shares.
- Stock Surge Context: Cogent's stock skyrocketed over 342% in 2025, and this significant share sale has sparked speculation about management taking profits, although Fairmount's exact motives remain unclear; nonetheless, the over $120 million gain from this transaction is substantial.
- Holding Structure Analysis: Despite the large sale of common shares, Fairmount still holds approximately 67,414 units of Series A Convertible Preferred Stock, which could convert to about 16.85 million common shares, but due to a 9.9% ownership limit, they would need to sell some common shares first to facilitate this conversion.
- Investment Strategy and Market Performance: Fairmount Funds focuses heavily on biotech investments, with Cogent being a key part of its portfolio, showcasing potential in targeted therapies for rare diseases, and combined with its strong market performance, it may present long-term profit opportunities for investors.
See More
Fairmount Funds Sells 3.5 Million Shares of Cogent Biosciences
- Transaction Overview: On January 22, 2026, Fairmount Funds Management LLC indirectly sold 3.5 million shares of Cogent Biosciences for approximately $127.4 million, highlighting its investment strategy in the biotech sector.
- Change in Holdings: This transaction reduced Fairmount's indirect holdings by 38.87%, leaving 5,503,418 shares, which may indicate a potential shift in confidence regarding Cogent's future prospects.
- Market Context Analysis: At the time of the sale, Cogent's shares were priced at $36.40, lower than the closing price of $39.53 that day, suggesting a cautious market sentiment that could impact investor confidence.
- Investor Implications: Although Fairmount still holds about 67,414 units of Series A Convertible Preferred Stock, which could convert to approximately 16.85 million common shares, the 9.9% ownership limit will restrict future sales, affecting liquidity management.
See More
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.
See More
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.
See More
Cogent Biosciences Insider Sells 65,000 Shares for $2.52 Million
- Insider Sale: Evan Kearns, Chief Legal Officer of Cogent Biosciences, sold 65,000 shares on December 26 for a total of $2.52 million at a weighted average price of $38.70, reducing his direct holdings by 37.27%, indicating a cautious outlook on the company's future.
- Ownership Change: Following this transaction, Kearns's direct ownership stands at 109,398 shares, and this sale marks his only open-market transaction, with no derivatives or indirect holdings involved, maintaining his direct control over the company.
- Market Reaction: Kearns's sale did not trigger panic in the market, as it occurred after a significant stock price surge due to the company's public offering and clinical advancements, suggesting a normal liquidity management strategy at high valuations.
- Strategic Context: Cogent focuses on precision therapies for rare diseases, and Kearns's sale does not undermine the company's long-term strategy in oncology and rare disease markets, with future value hinging on clinical execution and regulatory progress.
See More
Cogent Biosciences' CLO Sells 65,000 Shares for $2.52 Million
- Reduction in Holdings: Evan Kearns, the Chief Legal Officer of Cogent Biosciences, sold 65,000 shares for $2.52 million, reducing his direct ownership by 37.27% to 109,398 shares, significantly lowering his direct exposure to the company's equity.
- Market Reaction: This transaction occurred after Cogent's stock surged following a public offering announcement in November, reflecting strong momentum in financing and clinical progress, although Kearns' sale may trigger short-term market fluctuations.
- Transaction Context: Kearns' sale is the only recorded open-market transaction, with all shares sold being directly held, indicating no involvement of derivatives or indirect interests, suggesting sustained confidence in the company's future.
- Investor Focus: While Kearns' sale may be viewed as insider liquidity, Cogent's long-term value will ultimately hinge on clinical execution and regulatory advancements rather than a single sale event.
See More
