INSYS Therapeutics (INSY) Stock Fires on All Cylinders; Here’s Why

Insys Therapeutics (NASDAQ:INSY) shares jumped 40% as of 2:28 p.m. EDT on Thursday in response to the announcement that one of the drug maker’s key compounds has received Fast Track designation from the FDA.

Insys stated that the FDA bestowed Fast Track designation upon its lead compound epinephrine nasal spray, as a hopeful treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment. The agency made this decision in response to data that the company had previously released showing that the bioavailability of the company’s novel, proprietary formulation of epinephrine delivered intranasally was similar to that of intramuscular injection with EpiPen (0.3 mg).

Insys SVP of regulatory affairs Steve Sherman was excited to share this news with investors: “The receipt of Fast Track designation represents a significant milestone for INSYS and our clinical development of this novel drug-device combination […] 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.”

According to the Mayo Clinic, more than 200,000 cases of anaphylaxis occur each year in the United States. The World Allergy Organization estimates that up to two percent of the global population—as many as 150 million people worldwide—will experience anaphylaxis during their lifetime.

Late last year, INSYS also received Fast Track designation for another of its product candidatesspecifically, cannabidiol (CBD) oral solution as an investigational treatment for the genetic condition Prader-Willi syndrome. Clinical development for that pipeline product is currently in Phase 2, with enrollment underway. The company’s proprietary formulation of pharmaceutical-grade CBD is also under evaluation for childhood absence epilepsy (Phase 2) and infantile spasms (Phase 3).

Analyst Ratings

TipRanks suggests caution has Wall Street fairly divided in its expectations on INSY. Out of 4 analysts polled in the last 6 months, 2 rate a Buy on Insys stock, 1 maintains a Hold, while 1 issues a Sell. When considering if this stock is an overvalued or undervalued contender in the market, it is worthy of note that analyst expectations indicate nearly 32% downside, with the 12-month average price target standing at $7.67. (See INSY’s price targets and analyst ratings on TipRanks.)

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