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Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meetingStrong financial posi Feb 17, 2026 - $COGT
Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
WALTHAM, Mass. and BOULDER, Colo., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced multiple upcoming posters highlighting bezuclastinib results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients at the 2026 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in Philadelphia, PA, February 27-March 2 Feb 10, 2026 - $COGT
Cogent Biosciences FDA Milestones Put Bezuclastinib And Valuation In Focus
Cogent Biosciences received FDA Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib in gastrointestinal stromal tumors (GIST). The FDA also accepted Cogent’s New Drug Application for bezuclastinib into the Real-Time Oncology Review program. These regulatory updates highlight potential changes for future treatment options in GIST if the drug is ultimately approved. Cogent Biosciences, traded as NasdaqGS:COGT, is drawing fresh attention with these back to back... Feb 2, 2026 - $COGT
Cogent Biosciences (COGT) Advances Bezuclastinib-Sunitinib Combination With Breakthrough Therapy Designation (BTD)
Cogent Biosciences, Inc. (NASDAQ:COGT) is one of the 11 Best Performing Stocks in the Last 12 Months. On January 26, 2026, Cogent Biosciences, Inc. (NASDAQ:COGT) announced a major milestone, receiving a Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration. The designation came for bezuclastinib in combination with sunitinib for patients with Gastrointestinal […] Feb 2, 2026 - $COGT
Cogent Biosciences announcse U.S. BTD for bezuclastinib
Cogent Biosciences (COGT) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation, BTD, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib. “We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with im Jan 27, 2026 - $COGT
Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
- Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in c Jan 26, 2026 - $COGT
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