Earnings summaries and quarterly performance for Cogent Biosciences.
Executive leadership at Cogent Biosciences.
Andrew Robbins
Detailed
Chief Executive Officer and President
CEO
CP
Cole Pinnow
Detailed
Chief Commercial Officer
EK
Evan Kearns
Detailed
Chief Legal Officer and Corporate Secretary
JS
Jessica Sachs
Detailed
Chief Medical Officer
JG
John Green
Detailed
Chief Financial Officer
JR
John Robinson
Detailed
Chief Scientific Officer
Board of directors at Cogent Biosciences.
Research analysts covering Cogent Biosciences.
Recent press releases and 8-K filings for COGT.
Cogent Biosciences Announces Positive Clinical Trial Results and NDA Submission Plans
COGT
New Projects/Investments
Guidance Update
- Cogent Biosciences, Inc. announced positive full results from its SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) on December 6, 2025. Bezuclastinib demonstrated clinically meaningful and statistically significant improvements across primary and key secondary endpoints, including a -24.3% mean change in Total Symptom Score (TSS) at 24 weeks compared to -15.4% for placebo (p<0.001).
- The company also announced positive top-line results from its APEX clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) on December 8, 2025. The APEX trial showed a 57% Overall Response Rate (ORR) per mIWG criteria and an 80% ORR per pure pathological response criteria.
- Based on these results, Cogent Biosciences expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026.
- This marks the third positive pivotal trial result for bezuclastinib in 2025, following the SUMMIT trial in NonAdvSM and the PEAK trial in GIST patients.
Dec 8, 2025, 9:05 PM
Cogent Biosciences Reports Positive SUMMIT Trial Results for Bezuclastinib in Non-Advanced Systemic Mastocytosis
COGT
- Bezuclastinib achieved its primary endpoint in the SUMMIT trial for Non-Advanced Systemic Mastocytosis (NonAdvSM), demonstrating rapid, durable, statistically significant, and clinically meaningful symptom improvement.
- Patients treated with bezuclastinib showed a mean total symptom score (TSS) reduction of -24.32 at Week 24, compared to -15.41 for placebo.
- The drug significantly reduced objective disease markers, including serum tryptase (≥50% reduction in 95.4% of patients), bone marrow mast cell burden (≥50% reduction in 88.2%), and KIT p.D816V variant allele frequency (≥50% reduction in 97.5%).
- 55% of patients receiving bezuclastinib no longer met WHO Diagnostic Criteria, and 91% achieved a Pure Pathologic Response at 24 weeks.
- An NDA submission for a broad NonAdvSM population is expected by the end of 2025, with a global annual market opportunity exceeding $3 billion.
Dec 8, 2025, 1:00 PM
Cogent Biosciences Announces Positive Bezuclastinib Trial Results and Market Leadership Outlook
COGT
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Cogent Biosciences announced positive top-line results from its APEX pivotal trial for advanced systemic mastocytosis (SM) and full results from the SUMMIT trial for non-advanced SM, both for bezuclastinib.
- Bezuclastinib is positioned for market leadership across three patient populations, with a global annual market potential of over $7.5 billion.
- In the APEX trial, bezuclastinib achieved a 57% response rate (modified IWG-MRT-ECNM criteria) and an 80% partial response or better on pure pathological response, with a median time to response of two months. Importantly, no patients discontinued treatment due to related adverse events.
- For the SUMMIT trial, 97.5% of patients achieved at least a 50% reduction in total symptom score at week 24, demonstrating rapid, durable, and clinically meaningful symptom improvement.
- The company plans to submit all three New Drug Applications (NDAs) within the next several months, targeting a launch of bezuclastinib in systemic mastocytosis and GIST by the end of 2026.
Dec 8, 2025, 1:00 PM
Cogent Biosciences Announces Positive Pivotal Trial Results for Bezuclastinib
COGT
Product Launch
Guidance Update
New Projects/Investments
- Cogent Biosciences announced positive top-line results from its APEX pivotal trial for advanced systemic mastocytosis (SM) patients and full results from the SUMMIT trial for non-advanced SM patients, in addition to positive results from the PEAK trial for GIST patients.
- In the SUMMIT trial, bezuclastinib demonstrated a 97.5% reduction of at least 50% in the MS2D2 total symptom score, with 55% of patients no longer meeting diagnostic criteria for the disease after 24 weeks. The drug showed a favorable and manageable safety profile, with most common adverse events being hair color changes and altered taste.
- The APEX trial for advanced SM patients achieved a 57% response rate on the primary endpoint (modified IWG-MRT-ECNM criteria) and an 80% partial response or better on pure pathological response. No patients discontinued treatment due to related adverse events, and only 14.8% required a dose reduction.
- Based on these results, bezuclastinib is positioned for market leadership across all three patient populations (SM and GIST), with a global annual market potential of over $7.5 billion.
- Cogent plans to submit all three New Drug Applications (NDAs) within the next several months, with the NDA for indolent systemic mastocytosis (ISM) expected in December and for advanced SM in the first half of 2026 , aiming for launch by the end of 2026.
Dec 8, 2025, 1:00 PM
Cogent Biosciences Presents Full SUMMIT Results
COGT
Product Launch
New Projects/Investments
- Cogent Biosciences announced complete results from Part 2 of the SUMMIT clinical trial for bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM), demonstrating clinically meaningful and highly statistically significant improvements across primary and key secondary endpoints. The company received Breakthrough Therapy Designation for bezuclastinib in October 2025 and is on track to submit its New Drug Application (NDA) in December 2025.
- Key efficacy results from the SUMMIT trial are presented below :
| Metric | 24 Weeks | 48 Weeks |
|---|---|---|
| Mean change TSS (%) (Bezuclastinib) | -24.3 (-43%) | -32.0 (-54%) |
| Mean change TSS (%) (Placebo) | -15.4 (-29%) | N/A |
| Proportion of patients with ≥50% reduction in TSS (Bezuclastinib) | 34.3% | 56.4% |
| Proportion of patients with ≥50% reduction in TSS (Placebo) | 18.1% | N/A |
- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use, with the majority of treatment emergent adverse events (TEAEs) being low grade. The most frequent TEAEs reported were hair color change (69.5% bezuclastinib vs. 5.0% placebo) and altered taste (23.7% bezuclastinib vs. 0% placebo).
Dec 6, 2025, 2:30 PM
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
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