Emergent BioSolutions Inc. EBS announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted PRIority Medicines (PRIME) designation to its chikungunya vaccine candidate CHIKV VLP.
The EMA grants PRIME status to drugs with a major therapeutic advantage over the existing treatments and target an unmet medical need or benefit patients without treatment options.
Management stated that the prestigious designation was granted to CHIKV VLP by CHMP at its September meeting. The candidate is being developed for the prevention of disease caused by chikungunya virus infection, which has a significant unmet medical need with no vaccines presently available.
We remind investors that in May 2018, CHIKV VLP was granted a similar designation, which is the Fast Track tag by the FDA.
Emergent plans to initiate a pivotal study on CHIKV VLP in 2020.
Shares of Emergent have lost 11.5% so far this year compared with the industry’s decrease of 9%.
Notably, in April 2019, Emergent announced positive interim results from the phase II study on CHIKV VLP, which evaluated its safety and immunogenicity across a series of dosing regimens.
Back then, interim data from the study showed that by day 7, a single dose of the vaccine produced a neutralizing antibody response in almost 98% patients, who are affected by the chikungunya virus. The positive immune responses were sustained through the six-month visit of the patients even with a single dose of the vaccine.
Emergent has a strong vaccine portfolio. The company's key Biodefense product BioThrax is marketed for the general use in both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease.
Emergent is also developing a next-generation anthrax vaccine candidate AV7909 for post-exposure prophylaxis of anthrax disease in a phase III study.
This apart, Emergent 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.
Meanwhile, the company is conducting a phase I study on VLA1601 (Zika virus vaccine) in partnership with France's Valneva SE. Last November, both companies announced favorable interim data from the phase I study on VLA1601.
Zacks Rank & Key Pick
Emergent currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Exact Sciences Corp. EXAS, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exact Sciences’ loss per share estimates have been narrowed 5.4% for 2019 and 10.1% for 2020 over the past 60 days. The stock has soared 43.5% year to date.
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