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COGT Rise as FDA Accepts Bezuclastinib NDA in Non-Advanced SM
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Key Takeaways
Cogent Biosciences gains as FDA accepts NDA for bezuclastinib in non-advanced SM patients.
COGT's SUMMIT study met all endpoints, showing significant symptom improvement and lasting benefits.
COGT highlights favorable safety, with more phase III studies and filings on bezuclastinib underway.
Cogent Biosciences (COGT - Free Report) announced that the FDA has accepted the new drug application (“NDA”) seeking approval for its lead pipeline candidate, bezuclastinib, for treating patients with non-advanced systemic mastocytosis (NonAdvSM).
With the FDA accepting the NDA for review, a decision from the regulatory body is expected on Dec. 30, 2026. The FDA also noted that no advisory committee is planned as of now and no review concerns have been identified.
Shares of Cogent Biosciences were up 4.9% yesterday following the announcement of the news.
The stock has increased 0.5% so far this year compared with the industry’s rise of 2.8%.
Image Source: Zacks Investment Research
COGT’s NDA for Bezuclastinib Based on SUMMIT Study
The above-mentioned NDA for bezuclastinib was based on data from the pivotal SUMMIT study.
The SUMMIT study achieved the primary and all key secondary endpoints, demonstrating clinically meaningful and highly statistically significant improvements following treatment with bezuclastinib in non-advanced SM patients.
Data from the SUMMIT study showed steadily deepening symptom improvement, suggesting lasting benefits following longer treatment with bezuclastinib. Patients who were treated with bezuclastinib did not just improve early on, but their symptoms kept getting better over time.
Treatment with bezuclastinib showed a favorable safety and tolerability profile, supporting its potential for chronic use in NonAdvSM, across the SUMMIT study.
COGT’s Other Development Activities With Bezuclastinib
The company is also evaluating bezuclastinib for another SM indication in a separate phase III study.
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.
The pivotal phase III APEX study is evaluating bezuclastinib for treating patients with advanced SM. The NDA for bezuclastinib in advanced SM is expected to be submitted in the first half of 2026.
Besides the SM indication, Cogent Biosciences is also developing bezuclastinib in combination with sunitinib for treating patients with gastrointestinal stromal tumors (“GIST”) who have received prior treatment with imatinib in the phase III PEAK study.
The NDA filing for the bezuclastinib combo for treating patients with second-line GIST is expected to be completed in April next month.
A potential approval for bezuclastinib is likely to give Cogent Biosciences the first commercial product and help it generate meaningful revenues.
Over the past 60 days, estimates for Phathom Pharmaceuticals’ 2026 earnings per share have increased from 24 cents to 28 cents, while the same for 2027 have increased from $2.22 to $2.25. PHAT’s shares have plunged 37.1% in the year-to-date period.
Phathom Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 14.06%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.14 to $8.72, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 8.6% in the year-to-date period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Replimune’s 2026 loss per share have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have declined 24.3% in the year-to-date period.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.
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COGT Rise as FDA Accepts Bezuclastinib NDA in Non-Advanced SM
Key Takeaways
Cogent Biosciences (COGT - Free Report) announced that the FDA has accepted the new drug application (“NDA”) seeking approval for its lead pipeline candidate, bezuclastinib, for treating patients with non-advanced systemic mastocytosis (NonAdvSM).
With the FDA accepting the NDA for review, a decision from the regulatory body is expected on Dec. 30, 2026. The FDA also noted that no advisory committee is planned as of now and no review concerns have been identified.
Shares of Cogent Biosciences were up 4.9% yesterday following the announcement of the news.
The stock has increased 0.5% so far this year compared with the industry’s rise of 2.8%.
Image Source: Zacks Investment Research
COGT’s NDA for Bezuclastinib Based on SUMMIT Study
The above-mentioned NDA for bezuclastinib was based on data from the pivotal SUMMIT study.
The SUMMIT study achieved the primary and all key secondary endpoints, demonstrating clinically meaningful and highly statistically significant improvements following treatment with bezuclastinib in non-advanced SM patients.
Data from the SUMMIT study showed steadily deepening symptom improvement, suggesting lasting benefits following longer treatment with bezuclastinib. Patients who were treated with bezuclastinib did not just improve early on, but their symptoms kept getting better over time.
Treatment with bezuclastinib showed a favorable safety and tolerability profile, supporting its potential for chronic use in NonAdvSM, across the SUMMIT study.
COGT’s Other Development Activities With Bezuclastinib
The company is also evaluating bezuclastinib for another SM indication in a separate phase III study.
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.
The pivotal phase III APEX study is evaluating bezuclastinib for treating patients with advanced SM. The NDA for bezuclastinib in advanced SM is expected to be submitted in the first half of 2026.
Besides the SM indication, Cogent Biosciences is also developing bezuclastinib in combination with sunitinib for treating patients with gastrointestinal stromal tumors (“GIST”) who have received prior treatment with imatinib in the phase III PEAK study.
The NDA filing for the bezuclastinib combo for treating patients with second-line GIST is expected to be completed in April next month.
A potential approval for bezuclastinib is likely to give Cogent Biosciences the first commercial product and help it generate meaningful revenues.
Cogent Biosciences, Inc. Price
Cogent Biosciences, Inc. price | Cogent Biosciences, Inc. Quote
COGT Zacks Rank & Stocks to Consider
Cogent Biosciences currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Phathom Pharmaceuticals (PHAT - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Replimune Group (REPL - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Phathom Pharmaceuticals’ 2026 earnings per share have increased from 24 cents to 28 cents, while the same for 2027 have increased from $2.22 to $2.25. PHAT’s shares have plunged 37.1% in the year-to-date period.
Phathom Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 14.06%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.14 to $8.72, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 8.6% in the year-to-date period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Replimune’s 2026 loss per share have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have declined 24.3% in the year-to-date period.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.