Chimerix Announces NDA Submission For Dordaviprone - Quick Facts

(RTTNews) - Chimerix (CMRX) said it has submitted a New Drug Application with the FDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma in the United States. Chimerix has requested Priority Review for the NDA.

Mike Andriole, Chief Executive Officer of Chimerix, said: "With this submission, we now turn our attention to preparing for potential commercial launch in the U.S. next year."

Also, the company entered into an amended and restated loan and security agreement for up to $30 million with Silicon Valley Bank, a division of First-Citizens Bank. Chimerix may draw down up to $20.0 million through the period ending February 28, 2026. An additional $10 million may also be made available upon request through February 28, 2027.

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