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Insys' Cannabidiol Gets Fast Track Designation in the U.S.

Zacks Equity Research

Insys Therapeutics, Inc.'s INSY shares increased more than 15% on Dec 26 after the company announced that its investigational cannabidiol (CBD) oral solution has been granted a fast track designation by the FDA for treatment of Prader-Willi syndrome. The company plans to move the candidate into clinical development late in the first quarter of 2018.

Notably, Prader-Willi syndrome is a genetic disorder in children that may eventually lead to obesity and type II diabetes.

The FDA grants a fast track designation to expedite a candidate’s development and its faster review, which treat serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review once it files a new drug application.

Per the company’s press release, Prader-Willi syndrome is one of the most common causes for life-threatening obesity in children in the United States. One of 15,000 children in the country is affected by this disease with no approved products available at the moment. Hence, there is a huge unmet need in this genetic disorder space, demanding an effective therapy to apprehend the disease.

Meanwhile, last week, the company announced initiation of a phase II study on CBD oral solution for treating refractory childhood absence epilepsy in pediatric patients. The study was designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of the candidate for the given indication.

Insys’ shares have significantly underperformed the industry so far this year. The stock has lost 10.9% against the industry’s rally of 23.7%.

We remind investors that a phase II study on its CBD product candidate is also being conducted for curing cocaine dependence. The phase II study is currently in progress under the supervision of Dr. Didier Jutras-Aswad, MD, at the University of Montreal Hospital Research Center and is supported by the Canadian Institutes of Health Research.

The company is evaluating the candidate for several additional indications including glioblastoma multiforme (GBM), pediatric schizophrenia and infantile spasms (IS).

Notably, another biopharmaceutical company, GW Pharmaceuticals plc GWPH, is also developing therapeutics from its proprietary cannabinoid product platform for addressing a broad range of diseases. The company has Sativex in its portfolio, the world’s first plant-derived cannabinoid prescription drug approved for treating spasticity due to multiple sclerosis.

Insys Therapeutics, Inc. Price

Insys Therapeutics, Inc. Price | Insys Therapeutics, Inc. Quote

Zacks Rank & Key Picks

Insys carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated CORT and Achillion Pharmaceuticals, Inc. ACHN, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Corcept’s earnings per share estimates have been revised upward from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 158.8% year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 4.51%.

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