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April 23, 2024 15:56 ET | Source: Day One Biopharmaceuticals, Inc.

Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor

Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Co
February 26, 2024 16:30 ET | Source: Day One Biopharmaceuticals, Inc.

Day One Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Progress

PDUFA target action date for tovorafenib NDA in relapsed or progressive pLGG remains set for April 30, 2024 Phase 2 FIREFLY-1 tovorafenib registrational data published in Nature Medicine Ended 2023...
January 17, 2024 08:00 ET | Source: Day One Biopharmaceuticals, Inc.

Day One Announces Two New Appointments to Board of Directors

BRISBANE, Calif., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and...
December 19, 2023 08:00 ET | Source: Day One Biopharmaceuticals, Inc.

Day One to Present at the 42nd Annual J.P. Morgan Healthcare Conference

BRISBANE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and...
November 17, 2023 07:00 ET | Source: Day One Biopharmaceuticals, Inc.

Day One Announces Tovorafenib FIREFLY-1 Data Published in Nature Medicine

BRISBANE, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and...
November 14, 2023 08:00 ET | Source: Day One Biopharmaceuticals, Inc.

Day One to Participate in the Piper Sandler 35th Annual Healthcare Conference

BRISBANE, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and...
November 06, 2023 16:30 ET | Source: Day One Biopharmaceuticals, Inc.

Day One Reports Third Quarter 2023 Financial Results and Corporate Progress

Day One Reports Third Quarter 2023 Financial Results and Corporate Progress
October 30, 2023 08:00 ET | Source: Day One Biopharmaceuticals, Inc.

Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
September 11, 2023 21:02 ET | Source: Day One Biopharmaceuticals, Inc.

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)

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 ...
September 11, 2023 08:30 ET | Source: Day One Biopharmaceuticals, Inc.

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)

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 ...