2020-11-05 07:13:20 CMRX Chimerix
11/05/20 11/0507:13 11/05/2007:13 | Chimerix reports Q3 EPS (18c), consensus (17c)Reports Q3 revenue $1.6M, consensus $960,000 "Throughout the third quarter we continued to make significant progress across a number of key initiatives," said Mike Sherman, CEO of Chimerix. "Of particular note was the completion of our rolling submissions to the U.S. Food and Drug Administration for the approval of brincidofovir as a medical countermeasure for smallpox. This milestone brings us one step closer to the company's first regulatory approval and to securing a potential procurement contract with BARDA to supply the U.S. Strategic National Stockpile, which we expect to take place around the time of a potential FDA approval. In addition, we expect to be notified of our Prescription Drug User Fee Act date relating to these submissions before the end of the year. In addition, we expect to initiate our Phase 3 study of DSTAT for the treatment of acute myeloid leukemia in early 2021. We were particularly encouraged by a recent meta-analysis of 11,151 patients covering 81 separate studies published in the Journal of the American Medical Association Oncology in which a link was suggested between minimal residual disease status and outcomes in patients with AML. Specifically, this large cohort meta-analysis showed that MRD-negative AML patients experience superior disease-free survival and overall survival rates when compared to patients that are MRD-positive. The study suggests that evaluation of MRD status in AML patients may allow for an earlier assessment of therapeutic effects and could lead to acceleration in the development of novel AML therapeutics. This meta-analysis underscores the importance of the MRD assessment that we will undertake following the first 80 evaluable patients in our Phase 3 study in order to better interpret the relapse-free survival and overall survival advantages observed with DSTAT in our smaller Phase 2 study. Due to the complex and rapidly changing landscape of the current pandemic, we cannot predict when we will complete enrollment in our Phase 2 trial of DSTAT in acute lung injury in COVID-19 but do anticipate sharing initial topline data in the first quarter of 2021." |
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