Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End
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Chimerix plans to submit a New Drug Application for dordaviprone to the FDA for accelerated approval as a treatment for recurrent H3 K27M-mutant diffuse glioma. The potential approval is expected in Q3 2025. The company will host a conference call on December 10, 2024, to discuss this development.
December 09, 2024 | 9:15 pm
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POSITIVE IMPACT
Chimerix is submitting an NDA for dordaviprone to the FDA for accelerated approval, targeting recurrent H3 K27M-mutant diffuse glioma. Approval could come by Q3 2025, potentially boosting the company's market position.
The submission of an NDA for accelerated approval indicates a significant step forward for Chimerix in bringing dordaviprone to market. If approved, this could lead to increased revenue and market share, positively impacting the stock price. The company's proactive communication with the FDA and the scheduled conference call suggest confidence in the approval process.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100