Chimerix (CMRX) Shares Lose Over -70 Percent after Antiviral Drug Fails Phase 3 Trial
Shares of Chimerix Inc. (CMRX) were trading down -27.92 or -78.49 percent to $7.65 per share in Monday’s premarket trading after the company announced early this morning that its lead product candidate had failed to meet its primary endpoint in a Phase 3 trial. Chimerix stock closed at $35. 57 per share in Friday’s regular trading session.
Durham, North Carolina based Chimerix Inc. was incorporated in 2000 as a biopharmaceutical company and had its initial public offering at $14 per share in 2013.
Brincidofovir, which has been in development for several years, received a Fast Track designation from the FDA for smallpox, adenovirus and CMV in 2014. The drug was used as an experimental Ebola drug in 2014; however Chimerix opted to end those tests in favor of applying the drug to treat other diseases such as CMV.
Chimerix announced early this morning that its lead drug, brincidofovir, had failed in its Phase 3 SUPPRESS trial in patients undergoing hematopoietic cell transplantation or HCT. The drug also failed to achieve its primary endpoint for the prevention of clinically significant cytomegalovirus or CMV infection through the 24th week of transplant.
Through the 14th week of treatment after HCT transplantation, fewer patients in the brincidofovir arm showed signs of CMV infection, which was consistent with positive antiviral effects noted in the Phase 2 trial. Nevertheless, the treatment from Week 14 to Week 24 showed an increase in CMV infections in the brincidofovir arm versus the control arm. In addition, there was a non statistically notable increase in mortality in the brincidofovir arm versus the control arm.
The company said that the primary endpoint failures in both mortality and the prevention of CMV infections were driven by confirmed cases of graft versus host disease or GVHD. The GVHD cases resulted in significantly higher use of corticosteroids in the brincidofovir arm compared to the control arm. The use of corticosteroids and GVHD are both risk factors in late CMV infection which occurs after discontinuing the use of the antiviral in HCT recipients
Michelle Berrey, M.D., MPH, President and Chief Executive Officer of Chimerix said in the company’s press release that, “While we are clearly disappointed in the top-line results from SUPPRESS, we remain committed to better understanding the full data set as we consider potential paths forward for brincidofovir, said With a strong cash position, an experienced leadership team, and brincidofovir patent exclusivity through 2034, we continue to believe there is a viable path forward for the development of brincidofovir.”
Chimerix stock has lost three quarters of its value so far today. While the news is extremely negative for the company, the reaction could be somewhat overdone. The stock is currently trading at half of its IPO valuation and might present an opportunity for the right investor.
Other News About CMRX
Chimerix, Inc. Earnings Q3, 2015
Company reported a net loss of -$32.45 million in the company’s latest quarter.
Stock was in 17 hedge fund portfolios at the end of the third quarter.
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