BioCryst Pharma (BCRX) Granted Orphan Drug and Fast Track Status from the FDA

Shares of BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX) are spiking 7% to $11.85 in pre-market trading Monday following the company’s announcement that the FDA has granted Fast Track designation for BCX4161, a novel, orally administered, selective inhibitor of plasma kallikrein in advanced clinical development for the treatment of hereditary angioedema.

BioCryst said that the Fast Track designation process of the FDA is designed to facilitate the development and expedite the review and approval of drugs intended to treat serious or life threatening conditions and that address unmet medical needs. A drug that receives Fast Track designation is usually eligible for more frequent written communication and meetings with the FDA to discuss the drug’s development plan and the collection of appropriate data supporting drug approval. Priority Review and Rolling Review may be granted, if relevant criteria are met. Rolling Review allows a drug company to submit completed sections of its New Drug Application (NDA) for review by FDA on an ongoing basis, rather than wait until the entire NDA is completed and then reviewed.

“We are very pleased to have been granted orphan drug and fast track status from the FDA, as well as recently receiving a positive opinion for orphan drug designation in Europe,” said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. “BCX4161 and our second generation molecules have the potential to significantly improve HAE patient treatment and their quality of life. We look forward to reporting results from OPuS-2 and sharing updates regarding BCX7353 and our other second generation HAE assets during 2015.”

BioCryst also said that it is enrolling HAE patients in the OPuS-2 trial of BCX4161; a double-blind, randomized, placebo controlled trial conducted in the U.S. and certain EU countries, with the goal of demonstrating the efficacy and safety of BCX4161 treatment for 12 weeks in approximately 100 patients with HAE. BioCryst expects to report results from OPuS-2 by the end of 2015.

BioCryst Pharmaceuticals, Inc. currently valued at $789.77M, has a median Wall Street price target of $18.00 with a high target of $24.00. Approximately shares have already changed hands, compared to the stock’s average daily volume of 872.13K.

In the past 52 weeks, shares of Durham, North Carolina-based biotechnology company have traded between a low of $7.29 and a high of $14.62 with the 50-day MA and 200-day MA located at $11.22 and $11.61 levels, respectively. Additionally, shares of BCRX trade at a P/E ratio of 0.87 and have a Relative Strength Index (RSI) and MACD indicator of 45.63 and -0.73, respectively.

BCRX currently prints a one year loss of about 10%, and a year-to-date loss of around 9.50%.

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