Cogent Biosciences Analysis (December) 2025 | Price, Valuation & Outlook

Cogent Biosciences

NasdaqGS:COGT

$ 39,55

+ $1,65 (4,35%)

39,55 $

+$1,65 (4,35%)

End-of-day quote: 12/19/2025

Cogent Biosciences Stock Value

According to analysts, the current valuation of NasdaqGS:COGT is Outperform.

Outperform

Cogent Biosciences Company Info

EPS Growth 5Y

41,15%

Market Cap

$6,02 B

Long-Term Debt

$0,00 B

Short Interest

3,66%

Annual earnings

02/25/2026

Dividend

$0,00

Dividend Yield

0,00%

Founded

Data Unavailable

Industry

Health Care

Country

United States

ISIN Number

US19240Q2012

Website

http://www.cogentbio.com

Analyst Price Target

$49,00

23.89%

Last Update: 12/20/2025

Analysts: 11

Highest Price Target $67,00

Average Price Target $49,00

Lowest Price Target $34,00

In the last five quarters, Cogent Biosciences’s Price Target has risen from $6,01 to $17,18 - a 185,86% increase. Eleven analysts predict that Cogent Biosciences’s share price will increase in the coming year, reaching $49,00. This would represent an increase of 23,89%.

Top growth stocks in the health care sector (5Y.)

What does Cogent Biosciences do?

Cogent Biosciences, Inc., a clinical-stage biotechnology company, focuses on developing precision therapies for genetically defined diseases. The company’s most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation, as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (‘SM’), a serious and rare disease caused...

Cogent Biosciences, Inc., a clinical-stage biotechnology company, focuses on developing precision therapies for genetically defined diseases.

The company’s most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation, as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (‘SM’), a serious and rare disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (‘GIST’), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib is a highly selective and potent KIT inhibitor, with the potential to provide a new treatment option for these patient populations. The company is developing bezuclastinib to treat patients living with Non-Advanced Systemic Mastocytosis (‘Non-AdvSM’), Advanced Systemic Mastocytosis (‘AdvSM’), and GIST. The company also has an ongoing Phase 1 study of its novel internally developed FGFR2 inhibitor, CGT4859. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases, initially targeting mutations in ErbB2, PI3Ka, and KRAS.

The company has assembled a management team with extensive experience in the research, development, manufacturing, and commercialization of pharmaceutical products, specifically including numerous successful precision medicines for genetically defined diseases.

Strategy

The principal components of the company’s strategy are to explore the clinical utility of bezuclastinib in patients with Non-AdvSM; explore the clinical utility of bezuclastinib in patients with AdvSM; explore the clinical utility of bezuclastinib in combination with sunitinib as a second-line treatment for patients with GIST; prepare to commercialize bezuclastinib should any or all of its active clinical trials demonstrate clinical benefit for patients with high unmet medical need; explore the clinical utility of CGT4859, a reversible, selective FGFR2 inhibitor in patients with documented FGFR mutations, including advanced cholangiocarcinoma; advance its ErbB2, PI3Ka, and KRAS preclinical programs, as well as its other undisclosed preclinical programs; and discover and develop additional precision medicines for patients with genetically defined diseases.

Pipeline

Bezuclastinib

Bezuclastinib is designed to target mutations within the KIT receptor tyrosine kinase, including KIT D816V. As a Type I inhibitor, bezuclastinib is designed to selectively bind the active conformation of mutant KIT. In preclinical studies, bezuclastinib has demonstrated comparable potency relative to other FDA-approved KIT mutant inhibitors, and clear selectivity for KIT mutations versus other kinase targets frequently associated with other KIT inhibitors, including, but not limited to, PDGFRa, PDGFRß, VEGFR2, FLT3, CSF1R, and KDR. In preclinical studies of bezuclastinib, limited blood-brain-barrier penetration was observed, and there have been no clinically significant CNS toxicities identified. This preclinical profile of selectivity against kinases that have been associated with off-target toxicities, and limited blood-brain-barrier penetration differentiate bezuclastinib from other KIT mutant inhibitors, and support the potential for a best-in-class clinical profile.

The company licensed the exclusive worldwide rights to develop and commercialize bezuclastinib from Plexxikon Inc., a Daiichi Sankyo subsidiary (‘Plexxikon’). Under the terms of the license agreement, Plexxikon received an upfront payment and is eligible for additional development and regulatory milestone payments, along with mid- to high-single-digit royalty payments.

SUMMIT (Non-AdvSM)

SUMMIT is the company’s registration-directed randomized, global, multicenter, double-blind, placebo-controlled, multi-part Phase 2 clinical trial for patients with Non-AdvSM. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Non-AdvSM, which includes Indolent Systemic Mastocytosis (‘ISM’), Smoldering Systemic Mastocytosis (‘SSM’), and Bone Marrow Mastocytosis. Based on the performance of bezuclastinib’s optimized formulation in the PEAK lead-in trial, as well as in a healthy normal volunteer study, the SUMMIT trial protocol was amended to allow for the optimized formulation to be introduced during the Phase 1b dose optimization phase. SUMMIT Part 1 completed enrollment in the third quarter of 2023, including over enrollment at 54 patients across Part 1a and Part 1b. SUMMIT Part 2 completed enrollment in the fourth quarter of 2024, including over enrollment at 179 patients. The company expects to report top-line results in July 2025.

From the data collected in Part 1 of SUMMIT, and in accordance with FDA guidelines, the company has developed a novel patient-reported outcomes measure (‘PROM’) called Mastocytosis Symptom Severity Daily Diary (‘MS2D2’). Based on literature review, patient and physician interviews, data from SUMMIT Part 1, and the company’s interactions with the FDA, its MS2D2 is a reliable, valid, and fit-for-purpose PROM. The MS2D2 Total Symptom Score (‘TSS’) consists of 11 items, and is scored on a 0-110 scale.

In February 2024, the company presented data from SUMMIT Part 1b at the 2024 American Academy of Allergy, Asthma and Immunology. Thirty-four patients were enrolled in Part 1b and were treated with either bezuclastinib or placebo plus best supportive care.

In December 2024, at the 2024 American Society of Hematology (‘ASH’) Annual Meeting, the company presented updated data on the 27 patients who were randomized in either Part 1 or the OLE to receive the 100 mg QD dose.

APEX (AdvSM)

APEX is the company’s registration-directed global, open-label, multi-center, Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. In April 2023, the company initiated Part 2 of the APEX trial using the optimized formulation of bezuclastinib at a 150 mg daily dose. An additional APEX cohort was initiated in the third quarter of 2023 and is designed to allow concomitant administration of bezuclastinib with azacitidine in patients with SM-AHN. The company completed enrollment in APEX Part 2 in the first quarter of 2025 with 58 patients and expects to present top-line results in the second half of 2025.

Bezuclastinib – GIST

Bezuclastinib is designed to be a potent and selective inhibitor of KIT exon 17 mutations. By combining bezuclastinib with sunitinib, a tyrosine kinase inhibitor known to inhibit KIT exon 13 mutations, this combination has the potential to offer a new, active treatment option for imatinib-resistant GIST patients.

PEAK (GIST)

PEAK is the company’s randomized open-label, global Phase 3 clinical trial designed to evaluate the safety, tolerability, and efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic GIST who have received prior treatment with imatinib. Patient enrollment for the pivotal portion of the PEAK trial was completed in the third quarter of 2024. Based on strong global patient interest, a total of 413 patients were enrolled in the trial. In addition, the company completed a pre-planned interim futility analysis, and the Independent Data Monitoring Committee (‘IDMC’) recommended continuing the PEAK study without modification. This pre-specified analysis was based on an assessment of PFS as determined by independent central review and did not include the option for early stopping due to efficacy. Top-line results are expected by the end of 2025.

In June 2024, the company presented updated positive clinical data from the lead-in portion of the PEAK trial at the 2024 annual ASCO meeting. As of April 1, 2024, the 42 patients in Part 1 had been on study for a median of 15.3 months. The median progression-free survival (‘mPFS’) on the combination of bezuclastinib and sunitinib was 10.2 months in all patients.

In May 2024, the company also announced the initiation of a new advanced Phase 2 clinical trial of bezuclastinib plus sunitinib in later-line GIST patients that is being sponsored by the Sarcoma Alliance for Research through Collaboration, and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute. The open-label, single-arm Phase 2 trial is designed to evaluate the mPFS, as well as the safety and tolerability of bezuclastinib plus sunitinib in 40 patients with GIST who have previously progressed on sunitinib. This trial is focused on later-line patients that are not eligible for PEAK and have limited treatment options.

In the first quarter of 2025, the company initiated an expanded access program in the United States for patients affected with advanced, metastatic, and/or unresectable GIST, intolerant to imatinib, or who received prior imatinib therapy for the treatment that resulted in disease progression, and who meet other inclusion and exclusion criteria.

CGT4859

The company’s research team is building a pipeline of small molecule inhibitors, with its first efforts aimed toward targeting currently undrugged mutations in fibroblast growth factor receptor (‘FGFR’). FGFR mutations are well-established oncogenic drivers in multiple diseases, but approved medicines fail to capture the full landscape of FGFR altered tumor types, with FGFR1-mediated hyperphosphatemia serving as the most common dose-limiting toxicity for pan-FGFR inhibitors. In April 2023, the company reported preclinical data at the American Association for Cancer Research (‘AACR’) 2023 Annual Meeting providing the first published evidence of CGT4859, a reversible, selective FGFR2 inhibitor with coverage of activating and emerging resistance mutations that spares inhibition of FGFR1. Preclinical data demonstrate a profile that delivers equipotent coverage across both key gatekeeper and molecular brake mutations (V564X, N549X) in FGFR2, while avoiding any evidence of FGFR1-linked hyperphosphatemia at efficacious plasma concentrations. In October 2023, the company presented updated preclinical data at the 2023 EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics (‘EORTC-NCI-AACR’). Preclinical data demonstrate a profile that exhibits low nanomolar potency on WT FGFR2 and FGFR2 mutations and is selective against the kinome, as well as a panel of ion channels and receptors. Exploratory pharmacokinetics studies conducted across species showed CGT4859 to be a low-clearance compound with high oral bioavailability. Further, in a mutant-driven mouse model, CGT4859 demonstrated dose-responsive tumor growth inhibition with complete regressions at 5 mg/kg PO, and was well-tolerated. In addition, as a reversible inhibitor, the Cogent program retains enzymatic potency against potential cysteine 491 mutations. The company is actively enrolling its Phase 1 study of CGT4859 in patients with FGFR2 mutations, including advanced cholangiocarcinoma. The trial will explore the safety, tolerability, and clinical activity of escalating doses of CGT4859, with a goal of selecting an active and well-tolerated dose for further clinical investigation.

Intellectual Property

The company’s patent portfolio consists of U.S. patents and foreign patents and patent applications that it in-licensed exclusively from Plexxikon, as well as additional patent applications it has filed on its own.

Bezuclastinib

With the acquisition of Kiq Bio LLC (‘Kiq’) on July 6, 2020, the company obtained an exclusive, sublicensable, worldwide license to patents and applications owned by Plexxikon pursuant to a license agreement between Plexxikon and Kiq (the ‘License Agreement’). The licensed patents and applications under the License Agreement cover bezuclastinib, its therapeutic uses, and methods of making bezuclastinib and intermediates. These patents and applications include issued patents in multiple territories, including, but not limited to, Australia, Brazil, Canada, China, Colombia, Europe (validated in Germany, Spain, France, Great Britain, Italy, the Netherlands, as well as various other EU countries), Hong Kong, India, Indonesia, Israel, Japan, Mexico, New Zealand, Peru, the Philippines, Republic of Korea, Russia, Singapore, South Africa, Taiwan, and the United States. The pending applications also include patent applications pending in Australia, Brazil, Canada, China, Egypt, Europe, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Philippines, Singapore, South Africa, and the United States. The issued U.S. patents covering bezuclastinib and its therapeutic uses are expected to expire in 2033 and 2034, and the issued foreign patents covering bezuclastinib and its therapeutic uses are expected to expire in 2033, without consideration of potential patent term extensions. Patent applications covering methods of making bezuclastinib and intermediates could potentially provide exclusivity through at least 2041. In 2023, the company filed U.S. and international patent applications seeking to protect its optimized formulation of bezuclastinib, which could potentially provide exclusivity through at least 2043.

FGFR2

The company owns two patent families directed to inhibitors of FGFR2 mutations. A first patent family covers compositions of matter of certain inhibitors of FGFR2 and methods of use. As of December 31, 2024, this patent family had one pending U.S. application and one pending international application. Any patents issuing from or claiming priority to these applications would be expected to expire in 2044, without consideration of potential patent term extensions. A second patent family covers compositions of matter of certain inhibitors of FGFR2 mutations and methods of use. As of December 31, 2024, this patent family had one pending U.S. application and one pending international application. Any patents issuing from or claiming priority to these applications would be expected to expire in 2044, without consideration of potential patent term extensions.

ErbB2

The company owns one patent family directed to inhibitors of ErbB2 mutations. This patent family covers compositions of matter of certain inhibitors of ErbB2 mutations and methods of use. As of December 31, 2024, this patent family had one pending U.S. application and one pending international application. Any patents issuing from or claiming priority to these applications would be expected to expire in 2044, without consideration of potential patent term extensions.

Licenses and Third-Party Research Collaborations

License Agreement with Plexxikon Inc.

In July 2020, the company obtained an exclusive, sublicensable, worldwide license to certain patents and other intellectual property rights to research, develop, and commercialize bezuclastinib.

Government Regulation

In addition to the foregoing, local, state, and federal laws regarding such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act, and the Toxic Substances Control Act, affect the company’s business. These and other laws govern its use, handling, and disposal of various biological, chemical, and radioactive substances used in, and wastes generated by, its operations.

History

The company was formerly known as Unum Therapeutics Inc. and changed its name to Cogent Biosciences, Inc. in 2020.

Cogent Biosciences Questions and Answers

Which sectors generate sales and which are the top 3 markets?

Revenue distribution by industry: Biotechnology: 100% (2025) TOP 3 markets and their percentage shares: USA: 70% Europe: 20% Asia-Pacific: 10% Cogent Biosciences, Inc. is a company specializing in the development of targeted therapies for rare genetic diseases and cancer. The majority...

At which locations are the company’s products manufactured?

Production Sites: No specific information available (2025) Cogent Biosciences, Inc. is a biopharmaceutical company focused on developing therapies for the treatment of rare genetic diseases. As a research-oriented company, it is possible that production is carried out by contract manufacturing organ...

What strategy does Cogent Biosciences pursue for future growth?

Focus on Clinical Development: Strengthening the pipeline through advanced clinical studies Partnerships and Collaborations: Expansion of strategic alliances with other biotech companies Innovative Therapies: Development of new targeted therapies for rare diseases Cogent Biosciences, Inc. pursues...

Which raw materials are imported and from which countries?

I'm sorry, but I do not have specific information about which raw materials or substances Cogent Biosciences, Inc. imports and from which countries they originate. Companies in the biopharmaceutical sector typically source various chemical compounds, biological materials, and laboratory supplies nec...

How strong is the company’s competitive advantage?

Market Share: Estimated at 5-7% in the area of targeted cancer therapies (2025) R&D Expenses: $45 million USD (2024) Cogent Biosciences, Inc. specializes in the development of targeted therapies for rare genetic diseases and cancer. The company's competitive advantage lies in its focus on innova...

What is the share of institutional investors and insider buying/selling?

Institutional Investor Ownership: 85% (estimated for 2025) Insider Buys: No significant purchases in the last year Insider Sells: Moderate sales in the last quarter The institutional investor ownership in Cogent Biosciences, Inc. is estimated to be around 85%. This suggests that the company is heavi...

What percentage market share does Cogent Biosciences have?

Market share of Cogent Biosciences, Inc.: Estimated 2-3% (2025) Top competitors and their market share: Amgen Inc.: 15% Gilead Sciences, Inc.: 12% Biogen Inc.: 10% Regeneron Pharmaceuticals, Inc.: 8% Vertex Pharmaceuticals Incorporated: 7% Moderna, Inc.: 6% BioNTech SE: 5% Novavax, Inc.: 4% Cogent...

Is Cogent Biosciences stock currently a good investment?

Revenue Growth: 35% (estimated 2024) Research and Development Expenses: 40% of revenue (2024) Pipeline Progress: Two drugs in Phase III (2025) Cogent Biosciences, Inc. is showing strong revenue growth, estimated to be around 35% in 2024. This indicates a positive development and a strong market posi...

Does Cogent Biosciences pay a dividend – and how reliable is the payout?

Dividend: None Cogent Biosciences, Inc. currently does not pay a dividend. The company operates in the biotechnology sector, where it is common to reinvest profits in research and development rather than distributing dividends. This is especially the case for companies in the growth phase that focus...

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Cogent Biosciences Stock Value

Cogent Biosciences Company Info

Analyst Price Target

Top growth stocks in the health care sector (5Y.)

What does Cogent Biosciences do?

Cogent Biosciences Questions and Answers

Offer & Services

Service & Collaboration

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