COGT Stock Skyrockets 120% in a Month: Here's What You Need to Know

Shares of Cogent Biosciences COGT have skyrocketed 120.3% in a month. The stock price rally was primarily driven by positive data readout from a late-stage study of its investigational combo therapy, bezuclastinib plus sunitinib, in second-line gastrointestinal stromal tumors (GIST) patients.

Cogent Biosciences’ phase III PEAK study evaluated the bezuclastinib/sunitinib combo against sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST.

COGT’s Phase III GIST Study Data in Detail

Per the data readout, Cogent Biosciences’ combo regimen delivered a substantial and highly statistically significant clinical benefit on the primary endpoint of progression-free survival (PFS) compared with sunitinib alone. As of the Sept. 30, 2025, data-cutoff, the regimen reduced the risk of disease progression or death compared to the current standard of care by 50%, achieving a median PFS of 16.5 months compared to 9.2 months with sunitinib monotherapy, based on blinded independent central review.

In addition to the PFS benefit, the bezuclastinib combination achieved a 46% objective response rate (ORR), notably higher than the 26% ORR observed with sunitinib alone in imatinib-resistant patients, underscoring its superior antitumor activity. While overall survival data remain immature, the durability of treatment appears promising. Given the encouraging responses and the number of patients still receiving therapy in the bezuclastinib arm, the estimated mean duration of treatment is projected to exceed 19 months, indicating sustained clinical benefit.

Year to date, COGT shares have surged 347.9% compared with the industry’s 15.8% growth.

Cogent Biosciences’ bezuclastinib/sunitinib combo was generally well tolerated in the phase III PEAK study and demonstrated a favorable safety profile. No new or unexpected safety risks emerged with the novel combination relative to sunitinib’s established safety profile. Treatment-related adverse events were mostly mild to moderate in severity.

Based on the encouraging data, COGT believes that the combo regimen has the potential to become the new standard of care for second-line, imatinib-resistant or intolerant GIST, if approved. The company is also currently gearing up to submit a regulatory filing to the FDA, seeking the approval of the bezuclastinib combo for this GIST indication in the first half of 2026. Cogent Biosciences expects to present detailed results from the PEAK study at a medical conference in the first half of 2026.

COGT’s Other Pipeline Programs

Bezuclastinib is Cogent Biosciences’ lead clinical-stage pipeline candidate. Apart from the GIST indication, the company is also currently evaluating bezuclastinib for two systemic mastocytosis (SM) indications in separate phase III studies.

SM is a rare hematological disease impacting the immune system with debilitating symptoms that take a serious toll on the physical and psychological quality of life of patients.

In July 2025, Cogent Biosciences reported positive top-line data from a late-stage study of bezuclastinib for treating non-advanced SM patients. The registration-enabling phase III SUMMIT study achieved the primary and all key secondary endpoints, demonstrating clinically meaningful and highly statistically significant improvements upon treatment of non-advanced SM patients with bezuclastinib, over placebo. The data readout also includes significant improvements in patient-reported symptoms and objective measures of mast cell burden.

Based on the encouraging data readout, Cogent Biosciences is gearing up to submit its first new drug application to the FDA, seeking the approval of bezuclastinib for non-advanced SM, by the end of 2025. Subject to approval, management believes that the candidate has the potential to become a new standard of care for non-advanced SM patients, where there is a significant unmet medical need.

Cogent Biosciences is simultaneously evaluating bezuclastinib for advanced SM in the pivotal phase III APEX study, with top-line results anticipated in December 2025.

Cogent Biosciences, Inc. Price and Consensus

Cogent Biosciences, Inc. price-consensus-chart | Cogent Biosciences, Inc. Quote

COGT’s Zacks Rank and Stocks to Consider

Cogent Biosciences currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector include Arcutis Biotherapeutics ARQT, Editas Medicine EDIT and ADMA Biologics ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 100.2%.

Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.

In the past 60 days, estimates for Editas Medicine’s loss per share have narrowed from $2.12 to $2.06 for 2025. During the same time, loss per share estimates for 2026 have widened from $1.02 to $1.05. Year to date, shares of EDIT have rallied 98.5%.

Editas Medicine’searnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 13.17%.

In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 57 cents to 58 cents for 2025. During the same time, earnings per share estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have lost 7%.

ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.

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