Day One Biopharmaceuticals Has Submitted Rolling New Drug Application To The FDA For Tovorafenib In Relapsed Or Progressive Pediatric Low-grade Glioma. The Company Anticipates The FDA Will File The Rolling Application By Mid-November
Portfolio Pulse from Benzinga Newsdesk
Day One Biopharmaceuticals has submitted a rolling New Drug Application (NDA) to the FDA for Tovorafenib, a treatment for relapsed or progressive pediatric low-grade glioma. The company expects the FDA to file the application by mid-November.

September 11, 2023 | 12:35 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Day One Biopharmaceuticals' submission of a rolling NDA for Tovorafenib could potentially lead to a new revenue stream if approved by the FDA.
The submission of a new drug application is a significant step towards the commercialization of a drug. If the FDA approves Tovorafenib, it could potentially open a new revenue stream for Day One Biopharmaceuticals, positively impacting its stock price in the short term.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 100