Day One's OJEMDA Receives U.S. FDA Accelerated Approval For Relapsed Or Refractory BRAF-Altered Pediatric Low-Grade Glioma
Portfolio Pulse from Benzinga Newsdesk
Day One's OJEMDA has received accelerated approval from the U.S. FDA for treating relapsed or refractory pediatric low-grade glioma (pLGG) with BRAF alterations. It's the first FDA-approved type II RAF inhibitor for this condition, showing a 51% overall response rate in the RAPNO LGG study. Day One also received a rare pediatric disease priority review voucher. A conference call and webcast are scheduled for April 24, 8:30 a.m. Eastern Time.
April 23, 2024 | 7:58 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Day One's OJEMDA receives FDA accelerated approval for BRAF-altered pediatric low-grade glioma, a significant milestone for the company.
The FDA's accelerated approval of OJEMDA represents a significant milestone for Day One, potentially leading to increased investor confidence and positive market perception. This approval not only highlights the company's innovation in pediatric cancer treatment but also positions it favorably in the market. The receipt of a rare pediatric disease priority review voucher further underscores the importance of this approval, potentially adding financial value to the company through the sale or use of the voucher for future product approvals. The overall response rate of 51% in the RAPNO LGG study demonstrates the drug's efficacy, likely contributing to positive sentiment among investors and analysts.
CONFIDENCE 90
IMPORTANCE 100
RELEVANCE 100