On Monday, Chimerix ( CMRX ) announced that, following extensive dialogue with the FDA, the company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone for recurrent H3 K27M-mutant diffuse glioma in the U.S. before year-end.

A glioma is a tumor that originates in the glial cells of the brain or spinal cord and is the most common primary brain tumor.

Chimerix ( CMRX ) stock is trading higher on a strong session volume of 4.31 million, compared to an average volume of 497.04K, as per data from Benzinga Pro.

The following recent program milestones and additional supportive data were extensively discussed with the FDA and will be included in the NDA:

Substantial enrollment of the Phase 3 ACTION study.

Phase 2 objective response rate of the 50-patient primary efficacy analysis as the primary basis of efficacy in the NDA.

Several response assessments, under which dordaviprone demonstrated an objective response rate of 28%, a median duration of response of 10.4 months, and a median time to response of 4.6 months.

Additional clinical data sets and patient narratives supportive of the primary efficacy analysis.

Clinical and nonclinical demonstration of dordaviprone-driven reversal of the central hallmark of H3 K27M-mutant glioma, H3K27 trimethyl loss.

Comprehensive safety database of glioma patients and healthy volunteers that supports a favorable benefit/risk profile.

Comprehensive clinical pharmacology and chemistry, manufacturing, and controls (CMC) studies.

Chimerix ( CMRX ) will request a Priority Review for the NDA. If granted, the resulting six-month FDA review period is expected to result in a potential initial Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025.

Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and is eligible to apply for a Rare Pediatric Disease Priority Review Voucher.

“In anticipation of a potential approval, we have bolstered our commercial leadership team and will be ready for a U.S. launch as early as the third quarter of 2025, pending application acceptance and Priority Review, if granted,” said Mike Andriole, CEO of Chimerix ( CMRX ).

Price Action: CMRX stock is up 153.20% at $2.19 at last check on Tuesday.

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