Can BioCryst Turn Itself Around With This FDA Approval?

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BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) saw its shares make a handy gain in Thursday’s premarket after the firm received an update from the U.S. Food and Drug Administration (FDA). This approval is very welcome by BioCryst, which has underperformed the market so far this year.

Specifically, the agency approved a supplemental New Drug Application for Rapivab (peramivir injection), an intravenous neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older who have been symptomatic for no more than two days.

The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.

Jon P. Stonehouse, president and CEO, commented:

This approval represents the first new influenza antiviral for pediatric use in over 10 years. Rapivab provides another treatment option for pediatric patients with acute, uncomplicated influenza and represents another important milestone for BioCryst.

John A. Vanchiere, M.D., Ph.D., Chief, Section of Pediatric Infectious Diseases at LSU Health Sciences Center, commented:

Rapivab is a great addition to our armamentarium of antiviral agents to combat influenza. It will be especially helpful for patients who cannot tolerate oral medications.  In addition, the long half-life allows for one-time dosing which will improve compliance.

Excluding Thursday’s move, the stock is down about 17% year to date, while over the past 52 weeks it is actually up 16%.

Shares of BioCryst were up about 5% at $5.53 just after the opening bell but retreated after that. The consensus analyst price target is $9.11 and the 52-week trading range is $3.75 to $7.70.