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Emergent Starts Phase II Study on Anti-influenza Candidate


Emergent BioSolutions Inc. EBS announced that it has initiated a phase II dose-ranging study to evaluate its investigational immune globulin to treat influenza virus infection.

The study will evaluate the safety, pharmacokinetics and clinical benefit of FLU-IGIV, Emergent’s human polyclonal antibody, which has been developed as an intravenous treatment for influenza A infection in adult hospitalized patients.

Notably, the anti-influenza candidate is developed on the company’s established hyperimmune platform, which led to licensing of several marketed antibodies.

Shares of Emergent have outperformed the industry in a year’s time. The stock has surged 43.5% compared with the industry’s increase of 3.1%.

The phase II study was designed to evaluate FLU-IGIV in combination with the standard of care, including a minimum five-day administration of an anti-viral drug. It will be conducted on approximately 75 patients across 50 sites within the United States.

Per the company, seasonal influenza is a serious disease worldwide with possibility to cause severe diseases resulting in hospitalization and may even prove fatal for peril population. Hence, approval of this antibody will provide the company with an opportunity to access the potential market to cater to the unmet needs of patients, globally.

We remind investors that the company’s only polyclonal antibody therapeutic licensed by the FDA is Anthrasil, which was developed based on its established hyperimmune platform for the treatment of inhalational anthrax. Last month, the company announced that it has been awarded a contract by the Department of National Defence to deliver Anthrasil to the Canadian government.

Notably, Emergent is developing a next-generation anthrax vaccine candidate, NuThrax for post-exposure prophylaxis of anthrax disease, lying in advanced stages of development. The company expects to initiate a phase III study in early 2018 for the candidate. NuThrax is basically BioThrax, the only vaccine licensed by the FDA for its general prophylactic use combined with an adjuvant.

Zacks Rank & Other Key Picks

Emergent sports a Zacks Rank #1 (Strong Buy). Some other top-ranked stocks in the health care sector are Exelixis, Inc. EXEL, XOMA Corporation XOMA and Sucampo Pharmaceuticals, Inc. SCMP. While Exelixis and XOMA sport a Zacks Rank of 1, Sucampo carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Exelixis’ earnings per share estimates have been revised upward from 70 cents to 73 cents for 2018 over the last 60 days. The company pulled off an average positive earnings surprise in each of the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 112.7% in a year’s time.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 30 days. The company came up with an average positive earnings surprise of 47.92%. Share price of the company has skyrocketed 584.8% in the last 12 months.

Sucampo’s earnings per share estimates have moved north from $1.15 to $1.19 for the current year in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%. Share price of the company has surged 32.9% in a year.

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