Emergent BioSolutions Inc. EBS announced that it has initiated a phase III study to evaluate AV7909 for the post-exposure prophylaxis of anthrax disease. The phase III program will evaluate the lot consistency, immunogenicity and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule, administered intramuscularly in healthy adult patients.
AV7909 is currently being developed for post-exposure prophylaxis of anthrax disease, resulting from a suspected Bacillus anthracis exposure. The candidate is designed to lead to a faster immune response in patients as compared to the currently available anthrax vaccine.
The phase III program will enroll 3,850 patients and be conducted at various sites in the United States. The development and delivery of AV7909 is being funded by the Biomedical Advanced Research and Development Authority (BARDA).
We would like to remind investors that last December, Emergent submitted an application to the FDA for the emergency use authorization of its next-generation anthrax vaccine candidate, NuThrax, following a public health emergency involving Bacillus anthracis.
The company is developing NuThrax for the post-exposure prophylaxis of anthrax disease. The vaccine is in advanced stages of development with several phase I/II investigations already having evaluated its safety, efficacy and stability profile. The company currently anticipates that the FDA could authorize NuThrax for emergency use in the first half of 2019.
Notably, in September 2016, Emergent secured a multi-year contract worth about $1.6 billion with the BARDA for the advanced development and delivery of NuThrax.
Emergent’s key Biodefense product, BioThrax, 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.
The company also markets smallpox vaccine, ACAM2000, and anthrax monoclonal antibody, Raxibacumab. Both were acquired in the fourth quarter of 2017 from Sanofi SNY and GlaxoSmithKline GSK, respectively.
Shares of Emergent have decreased 17.1% so far this year against the industry’s increase of 15.8%.
Zacks Rank & Key Pick
Emergent currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Celgene Corporation CELG, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings estimates have moved 3.5% north for 2019 and 3.3% for 2020 over the past 60 days. The stock has surged 39% so far this year.
This Could Be the Fastest Way to Grow Wealth in 2019
Research indicates one sector is poised to deliver a crop of the best-performing stocks you'll find anywhere in the market. Breaking news in this space frequently creates quick double- and triple-digit profit opportunities.
These companies are changing the world – and owning their stocks could transform your portfolio in 2019 and beyond. Recent trades from this sector have generated +98%, +119% and +164% gains in as little as 1 month.
Click here to see these breakthrough stocks now >>
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
Sanofi (SNY) : Free Stock Analysis Report
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
Emergent Biosolutions Inc. (EBS) : Free Stock Analysis Report
Celgene Corporation (CELG) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research