Emergent BioSolutions, Inc. (EBS - Free Report) announced that the FDA has granted Orphan Drug status to BioThrax (anthrax vaccine adsorbed) for post-exposure prophylaxis of anthrax, resulting from exposure (suspected or confirmed) to bacillus anthracis.
The status offers seven years of marketing exclusivity to BioThrax in the U.S. through Nov 2022. It is granted to drugs that have the potential to treat diseases that affect less than 200,000 people in the U.S.
Currently, BioThrax is the only FDA-licensed vaccine for anthrax. It is indicated in the U.S. for the treatment of both pre-exposure and post-exposure prophylaxis of anthrax.
We note that in Apr 2016, Emergent BioSolutions submitted a supplemental Biologics License Application (sBLA) in the U.S., seeking a regulatory nod for manufacturing BioThrax in Building 55, the company’s large-scale manufacturing facility. The company believes that Building 55 has the potential to expand manufacturing capacity to an estimated 20–25 million doses a year, from the 7–9 million doses produced out of the current licensed facility.
We remind investors that the company has initiated a tax-free spin-off of the Biosciences business into a separate publicly traded company, Aptevo Therapeutics. Aptevo will focus on cancer and hematology treatments, while Emergent BioSolutions will continue to operate as a specialty biopharmaceutical company. This spin-off is anticipated to close shortly.
Emergent BioSolutions currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
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Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
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Emergent BioSolutions, Inc. (EBS - Free Report) announced that the FDA has granted Orphan Drug status to BioThrax (anthrax vaccine adsorbed) for post-exposure prophylaxis of anthrax, resulting from exposure (suspected or confirmed) to bacillus anthracis.
The status offers seven years of marketing exclusivity to BioThrax in the U.S. through Nov 2022. It is granted to drugs that have the potential to treat diseases that affect less than 200,000 people in the U.S.
Currently, BioThrax is the only FDA-licensed vaccine for anthrax. It is indicated in the U.S. for the treatment of both pre-exposure and post-exposure prophylaxis of anthrax.
We note that in Apr 2016, Emergent BioSolutions submitted a supplemental Biologics License Application (sBLA) in the U.S., seeking a regulatory nod for manufacturing BioThrax in Building 55, the company’s large-scale manufacturing facility. The company believes that Building 55 has the potential to expand manufacturing capacity to an estimated 20–25 million doses a year, from the 7–9 million doses produced out of the current licensed facility.
We remind investors that the company has initiated a tax-free spin-off of the Biosciences business into a separate publicly traded company, Aptevo Therapeutics. Aptevo will focus on cancer and hematology treatments, while Emergent BioSolutions will continue to operate as a specialty biopharmaceutical company. This spin-off is anticipated to close shortly.
Emergent BioSolutions currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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