On Monday, Chimerix (NASDAQ: 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 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:

Chimerix 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.

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

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This article Why Is Cancer-Focused Chimerix Stock Trading Higher On Tuesday? originally appeared on Benzinga.com

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