Emergent BioSolutions Inc. (EBS - Free Report) announced that it has submitted an application to the FDA for the emergency use authorization of its anthrax vaccine candidate, NuThrax, following a public health emergency involving Bacillus anthracis. The FDA will review the application and a decision is expected in the first half of 2019.
Emergent is developing its next-generation anthrax vaccine candidate, NuThrax, for post-exposure prophylaxis of anthrax disease. The vaccine is in advanced stages of development with several phase I/II studies having evaluated its safety, efficacy and stability profile.
NuThrax is intended to be a two-dose regimen, which will speed up protection, implying fewer doses accompanied by a more rapid protection compared with other available anthrax vaccines. The company is focusing on making NuThrax an EUA-eligible product for enabling deliveries to the Strategic National Stockpile (SNS) in 2019.
Notably, in September 2016, Emergent secured a multi-year contract worth about $1.6 billion with the Biomedical Advanced Research and Development Authority (BARDA) for advanced development and delivery of NuThrax. The preliminary procurement of NuThrax for inclusion in the SNS could be started in 2019 if this Emergency Use Authorization is approved by the FDA.
Shares of Emergent have rallied 26.3% year to date against the industry’s decline of 26%.
We would like to remind investors that BioThrax is Emergent’s key Biodefense product and is the sole vaccine to be marketed for the general use of both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease. The U.S. government is the primary purchaser of the company’s Biodefense products.
Emergent also markets smallpox vaccine, ACAM2000, and anthrax monoclonal antibody, Raxibacumab. Both were acquired in the fourth quarter of 2017 from Sanofi (SNY - Free Report) and GlaxoSmithKline (GSK - Free Report) , respectively.
In November this year, Emergent along with partner Valneva announced positive interim data from an early stage study on the Zika vaccine candidate, VLA1601. The candidate, currently evaluated in a phase I study, met the primary endpoint by achieving a favorable safety profile in all doses and schedules tested.
Initial data from the study also showed that VLA1601 led to a favorable immune response across all treatment groups. Final results from the program are anticipated in the first quarter of 2019.
Zacks Rank & Key Pick
Emergent currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Vanda Pharmaceuticals Inc. (VNDA - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda Pharmaceuticals’ earnings estimates have been revised 121.7% upward for 2019 over the past 60 days. The stock has soared 68.9% so far this year.
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