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Chimerx's (CMRX) NDA for Brincidofovir Accepted by FDA

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Chimerix Inc. ((CMRX - Free Report) ) announced that the FDA has accepted the filing of a new drug application (NDA) for brincidofovir (“BCV”) as a medical countermeasure for smallpox. The FDA granted Priority Review and set an action date of Apr 7, 2021.

Priority Review designation from the FDA is generally granted to drugs that have the potential of providing significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. A Priority Review designation accelerates the FDA's review time from 10 months to a goal of six months. At this time, the FDA is not planning to hold an advisory committee meeting to discuss the application.

Shares of the company have increased 123.7% year to date compared with the industry’s 2.7% growth.

Brincidofovir is an investigational therapy, which showed antiviral activity as a medical countermeasure against smallpox under the FDA’s Animal Efficacy Rule. Chimerix has developed brincidofovir under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority.

Chimerix has another candidate in its pipeline, namely dociparstat sodium (DSTAT). DSTAT is being studied in a phase II/III study to assess its safety and efficacy in adults with COVID-19 who also have acute lung injury. A phase III trial protocol to study DSTAT in acute myeloid leukemia has been developed in alignment with the FDA and the study is expected to be initiated in early 2021.

Zacks Rank & Stocks to Consider

Chimerix currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. (ARPO - Free Report) , Cara Thearpeutics Inc. (CARA - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.

Cara’s loss per share estimates have narrowed from $2.39 to $2.05 for 2020 and from $2.44 to $1.89 for 2021 over the past 60 days.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.

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