Earnings summaries and quarterly performance for Cogent Biosciences.
Executive leadership at Cogent Biosciences.
Board of directors at Cogent Biosciences.
Research analysts covering Cogent Biosciences.
Recent press releases and 8-K filings for COGT.
Cogent Biosciences Reports Positive PEAK Trial Results and Outlines Significant Market Opportunity
COGT
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- Cogent Biosciences announced positive results from its PEAK trial for bezuclastinib in second-line gastrointestinal stromal tumor (GIST) patients, demonstrating a median progression-free survival of 16.5 months and a 46% objective response rate. This represents a 50% reduction in the risk of progression or death.
- The company estimates the second-line GIST market opportunity to be over $4 billion in the U.S. and Europe, with no current competition. The total market opportunity for bezuclastinib across systemic mastocytosis and GIST is projected to be over $7.5 billion globally.
- Cogent plans to submit a New Drug Application (NDA) for the PEAK study in the first half of 2026, with potential approval by the end of 2026 if priority review is granted. Bezulcastinib has composition of matter protection through the end of 2038 and a formulation patent through the end of 2043.
Nov 19, 2025, 11:30 AM
Cogent Biosciences Reports Strong PEAK Trial Results for Bezuclastinib in GIST and Outlines Regulatory Path
COGT
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- Cogent Biosciences announced positive results from its PEAK trial for bezuclastinib in second-line gastrointestinal stromal tumor (GIST) patients, demonstrating a 16.5-month median progression-free survival and a 46% objective response rate for the combination therapy.
- The company plans to submit a New Drug Application (NDA) for bezuclastinib in second-line GIST in the first half of 2026, targeting a $4 billion market opportunity in the U.S. and Europe with no current competition.
- Cogent anticipates a readout for its APEX study in advanced systemic mastocytosis within weeks, contributing to a total global market opportunity of over $7.5 billion across GIST and mastocytosis indications.
- Bezulastinib is protected by intellectual property through 2038, with a potential extension to 2043 due to a pending formulation patent.
Nov 19, 2025, 11:30 AM
Cogent Biosciences Presents Positive PEAK Trial Results and Outlines Market Opportunity
COGT
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Cogent Biosciences (COGT) announced positive PEAK trial results for bezuclastinib in second-line gastrointestinal stromal tumor (GIST) patients, demonstrating a 16.5-month median progression-free survival and a 46% objective response rate.
- The company plans to submit a New Drug Application (NDA) for bezuclastinib in second-line GIST in the first half of 2026, targeting a market opportunity of over $4 billion in the U.S. and Europe with no current competition.
- An upcoming readout for the APEX study in advanced systemic mastocytosis is expected in a matter of weeks, contributing to a total estimated global opportunity of over $7.5 billion across GIST and systemic mastocytosis.
- Bezuclastinib's intellectual property is protected through the end of 2038 by composition of matter, with a pending formulation patent extending protection to the end of 2043.
Nov 19, 2025, 11:30 AM
Cogent Biosciences Announces Positive Phase 3 Bezuclastinib Combination Results for GIST
COGT
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Cogent Biosciences presented positive Phase 3 top-line results for its bezuclastinib combination therapy for imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST) at the Jefferies Global Healthcare Conference on November 19, 2025.
- The combination therapy demonstrated a 50% reduced risk of progression or death and a median Progression-Free Survival (mPFS) of 16.5 months, compared to 9.2 months for sunitinib alone.
- It achieved an Objective Response Rate (ORR) of 46% versus 26% for sunitinib alone, and was generally well tolerated with a favorable safety profile.
- An NDA submission for bezuclastinib in this indication is planned for 1H 2026, targeting a $4 billion+ global market for 2nd-line GIST.
Nov 19, 2025, 11:30 AM
Cogent Biosciences, Inc. completes $230 million convertible senior notes offering
COGT
Debt Issuance
Convertible Preferred Issuance
New Projects/Investments
- Cogent Biosciences, Inc. (COGT) completed a public offering of $230,000,000 aggregate principal amount of its 1.625% Convertible Senior Notes due 2031 on November 18, 2025, which included the full exercise of the underwriters' over-allotment option.
- These Notes are general, unsecured, senior obligations of the Company, accruing interest at 1.625% per year payable semiannually starting May 15, 2026, and will mature on November 15, 2031.
- The initial conversion rate for the Notes is 22.2469 shares of Common Stock per $1,000 principal amount, which translates to an initial conversion price of approximately $44.95 per share.
Nov 18, 2025, 9:09 PM
Cogent Biosciences Prices Concurrent Public Offerings
COGT
Debt Issuance
New Projects/Investments
- Cogent Biosciences priced an Equity Offering of 9,677,420 shares of common stock at $31.00 per share, and an offering of $200.0 million aggregate principal amount of 1.625% convertible senior notes due 2031.
- The estimated net proceeds from both offerings are approximately $475.3 million.
- The company intends to use these proceeds to repay $50 million of loans under its existing term loan facility, and the remainder for development and regulatory activities, anticipated commercial launch, and general corporate purposes.
- The Equity Offering is expected to close on November 13, 2025, and the Convertible Notes Offering on November 18, 2025.
Nov 13, 2025, 11:05 AM
Cogent Biosciences Prices Concurrent Public Offerings of Common Stock and Convertible Notes
COGT
Debt Issuance
New Projects/Investments
- Cogent Biosciences priced an equity offering of 9,677,420 shares of its common stock at $31.00 per share and an offering of $200.0 million aggregate principal amount of its 1.625% convertible senior notes due 2031.
- The equity offering was upsized, and the company estimates net proceeds from both offerings to be approximately $475.3 million.
- The company plans to use $50 million of the net proceeds to repay outstanding loans, with the remainder allocated for development and regulatory activities for bezuclastinib and other product candidates, anticipated commercial launch, and general corporate purposes.
- The convertible notes have an initial conversion price of approximately $44.95 per share, representing a conversion premium of approximately 45.0% above the public offering price of the common stock.
- The equity offering is expected to close on November 13, 2025, and the convertible notes offering on November 18, 2025.
Nov 12, 2025, 4:16 AM
Cogent Biosciences Reports Positive Phase 3 Trial Results for GIST Drug
COGT
Product Launch
New Projects/Investments
- Cogent Biosciences' stock surged over 100% following positive Phase 3 trial results for its combination therapy, bezuclastinib with sunitinib, for treating gastrointestinal stromal tumors (GIST).
- The trial demonstrated a median progression-free survival of 16.5 months compared to 9.2 months with sunitinib alone, and a higher objective response rate of 46% versus 26%.
- The therapy was generally well tolerated, and experts predict it could become the new standard of care, with the global market opportunity for bezuclastinib in GIST projected to exceed $4 billion.
- Cogent plans to submit a New Drug Application to the FDA in the first half of 2026.
- Despite the promising clinical data, the company currently faces financial challenges, including no recent revenue and ongoing losses.
Nov 10, 2025, 1:56 PM
Cogent Biosciences Reports Positive Phase 3 PEAK Trial Results for Bezuclastinib in GIST
COGT
Product Launch
New Projects/Investments
- Cogent Biosciences announced positive data from its Phase 3 PEAK trial for bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST).
- The combination demonstrated a median progression-free survival (mPFS) of 16.5 months compared to 9.2 months for sunitinib monotherapy, and an objective response rate (ORR) of 46% versus 26% for monotherapy.
- The safety profile of the bezuclastinib combination was well tolerated, with no unique risks observed when compared to the known safety profile of sunitinib.
- Cogent plans to submit a New Drug Application (NDA) for bezuclastinib in GIST in the first half of 2026.
Nov 10, 2025, 12:00 PM
Cogent Biosciences Reports Q3 2025 Financial Results and Key Clinical Milestones
COGT
Earnings
Guidance Update
Product Launch
- Cogent Biosciences reported a net loss of $80.9 million for the third quarter of 2025.
- The company anticipates top-line results from its Phase 3 PEAK trial in November 2025 and pivotal APEX results in December 2025, with a New Drug Application (NDA) filing for bezuclastinib in NonAdvSM on track for year-end 2025.
- As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $390.9 million, which, combined with $39.0 million from recent at-the-market (ATM) sales, is expected to fund operations into 2027.
- Bezuclastinib received Breakthrough Therapy Designation for certain NonAdvSM patient populations, following positive top-line results from the SUMMIT trial.
Nov 3, 2025, 2:13 PM
Quarterly earnings call transcripts for Cogent Biosciences.
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