Brief: Day One Announces New Firefly-1 Data For Tovorafenib (Day101) And Initiation Of Rolling NDA Submission To FDA
04/06/2023 17:48
June 4 (Reuters) - Day One Biopharmaceuticals Inc
DAWN.O :
* DAY ONE ANNOUNCES NEW FIREFLY-1 DATA FOR TOVORAFENIB
(DAY101)
AND INITIATION OF ROLLING NDA SUBMISSION TO FDA FOR RELAPSED OR
PROGRESSIVE PEDIATRIC LOW-GRADE GLIOMA
* DAY ONE BIOPHARMACEUTICALS-OVERALL RESPONSE RATE (ORR) OF
67%,
CLINICAL BENEFIT RATE (CBR) OF 93% IN 69 HEAVILY PRETREATED
RANO-HGG EVALUABLE PATIENTS
* EXPECTS TO COMPLETE ROLLING NDA SUBMISSION IN OCTOBER 2023
Source text for Eikon: ID:nGNX44mW2c
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