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Monday, September 11, 2023

Day One Completes NDA Submission for Relapsed or Progressive Pediatric Low-Grade Glioma

 Overall response rate (ORR) greater than 50% across three assessment criteria

Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment

FDA filing decision expected by mid-November


https://www.globenewswire.com/news-release/2023/09/11/2740811/0/en/Day-One-Announces-Updated-FIREFLY-1-Data-for-Tovorafenib-and-Completion-of-Rolling-NDA-Submission-to-FDA-for-Relapsed-or-Progressive-Pediatric-Low-Grade-Glioma-pLGG.html

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