Chimerix (NASDAQ:CMRX) has announced its Q3 financial and operational updates for the quarter ended September 30, 2020.
Chimerix to supply the US Strategic National Stockpile with BCV
The company’s CEO, Mike Sherman, said that throughout the quarter, the company continued to make considerable progress in various initiatives. Most notable was the completion of the rolling submissions to the FDA for brincidofovir (BCV) approval as a smallpox medical countermeasure. Sherman said that this milestone brings the company a step closer to its first regulatory approval and to securing a possible procurement deal with BARDA to supply the Strategic National Stockpile. The deal is likely to take place around the time of the possible FDA approval. Chimerix also expects notification from the FDA regarding PDUFA date related to the submissions.
Additionally, the company is excepting the commencement of the third phase DSTAT study for acute myeloid leukaemia (AML) treatment in early 2021. Recently the company published an encouraging meta-analysis of 11,151 patients in the Journal of American Medical Association Oncology. The analysis suggested a link between minimal residual disease status and AML patient outcomes. Interestingly the large cohort meta-analysis showed that MRD-negative AML patients had superior disease-free survival and overall survival rates compared to MRD-positive patients. This study suggests that MRD status in AML patients evaluation could permit earlier assessment of therapeutic effect, which could result in expedited development of proprietary AML therapeutics.
Chimerix completes BCV NDA submission
In Q3 the company completed rolling NDA submission for BCV suspension and BCV tablets as smallpox medical countermeasure. The company published in Advances in Therapy in a manuscript titled, “Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparsta in Acute Lung Injury Associated with Severe COVID-19.” The company also presented data supporting the multi-stage modelling and simulation approach for determining BCV dosing for smallpox treatment at the World Health Organisation Advisory Committee on Variola Virus Research.
The company expects FDA notification on acceptance of BCV NDA submission in Q4 2020 and assignment of PDUFA action date. Chimerix will commence Phase 3 DSTA trial in AML in early next year.