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Thursday, August 30, 2018

Insys epinephrine nasal spray granted fast-track designation


Shares of Insys Therapeutics Inc. INSY, +34.05% shot up 27% in very active afternoon trade Thursday, after the company said earlier that its epinephrine nasal spray was granted fast track designation from the Food and Drug Administration as an investigational treatment for anaphylaxis, which is a life-threatening allergic reaction. Volume spiked to 5.6 million shares, compared with the full-day average of about 480,000 shares. The company said that in a previous clinical trial, Insys’s product showed promise as a potential “needle-free, non-invasive and easy-to-use alternative” to intramuscular injection. “The receipt of Fast Track designation represents a significant milestone for Insys and our clinical development of this novel drug-device combination,” said Steve Sherman, senior vice president of regulatory affairs for Insys. “We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible.” The stock has now rallied 5.4% year to date, while the S&P 500 SPX, -0.44% has tacked on 8.9%.

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