Insys Therapeutics, Inc. (INSY: NASDAQ) announced that the FDA granted them orphan drug designation for their treatment of glioma. A glioma is a type of tumor that arises from the glial cells of the brain or, less commonly, the spine. Glioma accounts for approximately 30% of all brain and central nervous system tumors and 80% of all malignant brain tumors.
INSY was previously granted this designation for their treatment of glioblastoma multiforme (GBM) and two rare forms of epilepsy, Lennox-Gastaut Syndrome and Dravet Syndrome.
Orphan drug designation is granted to drugs that treat rare diseases that affect less than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as certain financial incentives that can help support its development.
INSY has 7+ years of research and development experience in the pharmaceutical cannabinoid space. They manufacture pharmaceutical CBD and pharmaceutical dronabinol (THC) at their FDA-inspected and DEA approved facility in Round Rock, Texas. INSY submitted a Drug Master File (DMF #28255) for its CBD active pharmaceutical ingredient. The company believes that they are the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.
INSY is up over 50% since early August and think they have a legs left to its run due to their extensive pipeline of drugs, as well as them trading on the NASDAQ exchange. The stock has been on a nice run recently and positive results from FDA testing should help push the stock to the low to mid 40s.
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