Why Day One Biopharmaceuticals (DAWN) Shares Are Trading Higher Premarket Today? - Day One Biopharmaceutical (NASDAQ:DAWN)

Day One Biopharmaceuticals DAWN announced topline results from the ongoing Phase 2 FIREFLY-1 trial evaluating tovorafenib (DAY101) as a monotherapy in recurrent or progressive pediatric low-grade glioma (pLGG).
Pediatric low-grade glioma is the most common brain tumor diagnosed in children.
Additional data will be submitted for presentation at an upcoming medical meeting in the second quarter of 2023.
Overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% were observed in 69 heavily-pretreated, RANO-evaluable patients.
Related: This Pediatric Cancer Company Makes It To Analyst's Conviction List.
Based on 77 treated patients, safety data indicated monotherapy tovorafenib to be generally well-tolerated.
The most common side effects reported related to tovorafenib were change in hair color (75%), increased creatine phosphokinase (64%), anemia (46%), fatigue (42%), and maculopapular rash (42%).
In addition to FIREFLY-1, Day One is expanding the development of tovorafenib as a front-line therapy for patients newly diagnosed with pLGG.
The global, Phase 3, registrational FIREFLY-2/LOGGIC clinical trial is evaluating once-weekly monotherapy tovorafenib in newly-diagnosed patients with pLGG harboring a known activating RAF alteration.
Price Action: DAWN shares are up 23.70% at $26.39 during the premarket session on the last check Monday.

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