Reports Q3 revenue $26,000, consensus $70,000. “We have sustained execution of the Phase 3 ACTION study and continue to be encouraged by the safety profile of dordaviprone following the Independent Data Monitoring Committee’s preplanned safety review which recommended continuing study conduct as-is, including at the more intense twice per week dose. Additionally, the Therapeutic Goods Administration has granted orphan drug designation to dordaviprone, and we have alignment to file a New Drug Application for Provisional Approval in Australia which we expect to occur in the coming months,” said Mike Andriole, Chief Executive Officer of Chimerix (CMRX). “As we complete the dordaviprone NDA and look toward the balance of the year, we also expect to complete enrollment in a Phase 1 dose escalation study of ONC206 as we consider future development scenarios for this program. In addition, we were delighted to announce the promotion of Dr. Josh Allen to the role of Chief Scientific Officer this quarter. Josh has been instrumental in the discovery and development of the imipridone class of compounds and expect his broad expertise in cancer biology and strong business acumen will underpin Chimerix early phase development for years to come,” added Mr. Andriole.
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