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Cogent Biosciences Announces Positive FDA Meeting and Alignment on MS2D2, a Novel Patient Reported Outcome Measure for the SUMMIT trial [Yahoo! Finance]

Cogent Biosciences, Inc. (COGT) 
Last cogent biosciences, inc. earnings: 11/8 04:05 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.cogint.com/investor-relations
Company Research Source: Yahoo! Finance
WALTHAM, Mass. and BOULDER, Colo., June 27, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Company's novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), for use in Part 2 of the registration-directed SUMMIT trial evaluating bezuclastinib in Nonadvanced Systemic Mastocytosis (NonAdvSM) patients. “We recently completed a positive discussion with the FDA on the use of MS2D2 in our SUMMIT trial for Nonadvanced Systemic Mastocytosis patients,” said Andrew Robbins, Cogent's President and Chief Executive Officer. “We remain on track to complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by year-end 2025.” Cogent's questionnaire, MS2D2, asks patients about their symptoms at baseline and measures Show less Read more
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