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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).
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Chimerx's (CMRX) NDA for Brincidofovir Accepted by FDA
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. , 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.
Chimerix, Inc. Price
Chimerix, Inc. price | Chimerix, Inc. Quote
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>