24/7 Market News Snapshot 18 February, 2025 – Chimerix, Inc. (NASDAQ:CMRX)

February 18, 2025

DENVER, Colo., 18 February, 2025 (247marketnews.com) – (NASDAQ:CMRX) are discussed in this article.
Chimerix, Inc. has demonstrated significant market activity following the FDA’s acceptance of its New Drug Application (NDA) for dordaviprone, which targets patients with recurrent H3 K27M-mutant diffuse glioma. Opening the trading day at $5.05, the stock surged to a current price of $5.045, representing an impressive 15.18% increase from the previous day’s close at $4.38. With a trading volume of 3.19 million shares, investor interest is palpable, suggesting positive sentiment surrounding the company following this key announcement.

The FDA’s acceptance of the NDA for dordaviprone has granted it Priority Review status, indicating the agency’s recognition of the drug’s potential to fulfill an unmet medical need. The Prescription Drug User Fee Act (PDUFA) target action date is scheduled for August 18, 2025, and notably, the FDA has opted not to hold an advisory committee meeting regarding this application. This expedited review process underscores Chimerix’s commitment to increasing access to therapeutics for patients with this challenging diagnosis, which historically has had limited treatment options.

Mike Andriole, the CEO of Chimerix, emphasized the significance of this milestone, stating the company is eager to collaborate with the FDA to expedite the review and potential commercialization of dordaviprone for patients in need. The drug, also known as ONC201, targets critical biological pathways and has previously received Rare Pediatric Disease Designation, furthering its potential impact in pediatric oncology.

Chimerix continues to focus on innovative therapies, including ongoing development efforts for another investigational product, ONC206. These initiatives reflect the company’s steadfast commitment to addressing high unmet medical needs in severe and complex conditions.

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