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BioCryst's Peramivir Filed in the U.S.

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Investors eagerly wait for updates on the pipelines of pharma/biotech companies. Such updates play an important role in deciding whether or not to invest in a particular company. Pipeline updates provide information on experimental drugs and also provide an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Last week, BioCryst Pharmaceuticals, Inc. (BCRX) filed a New Drug Application (:NDA) for peramivir to the U.S. Food & Drug Administration (:FDA). BioCryst is looking to get peramivir approved for the treatment of adults suffering from acute uncomplicated influenza. Once approved, BioCryst plans to launch peramivir in the U.S. during the 2014-15 influenza season.

We note that peramivir’s NDA submission was based on results from 27 clinical studies (n=2700). BioCryst was granted a small business waiver of the application fee for filing the peramivir NDA. The drug is already approved in Japan and Korea under the trade name Rapiacta for the treatment of influenza.

We are encouraged by BioCryst’s first NDA filing in the U.S. We expect investor focus to remain on peramivir going forward. Currently approved influenza vaccines include AstraZeneca’s (AZN) intranasal influenza vaccine FluMist Quadrivalent and Sanofi’s (SNY) quadrivalent formulation of Fluzone.

Apart from peramivir, BioCryst also has BCX4430 and ulodesine in its pipeline. While BCX4430 is being developed for the treatment of Marburg virus disease, ulodesine is being developed for the treatment of gout.

BioCryst presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Jazz Pharmaceuticals (JAZZ). The stock holds a Zacks Rank #1 (Strong Buy).

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