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NEW YORK, NY / ACCESSWIRE / August 31, 2018 / Both INSYS Therapeutics and REGENXBIO were soaring in Thursday’s session on positive developments. INSYS was given fast track designation from the FDA for its epinephrine nasal spray as an investigational treatment for anaphylaxis. REGENXBIO announced that it is developing a new product candidate, RGX-181, for the treatment of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease.

RDI Initiates Coverage on:

INSYS Therapeutics, Inc.


INSYS Therapeutics, Inc. shares blasted off on Thursday to see gains of almost 34% after the company announced that the Food and Drug Administration has given its epinephrine nasal spray fast track designation as an investigational treatment for anaphylaxis; a life-threatening allergic reaction. According to the company, 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 company’s senior vice president of regulatory affairs remarked, “The receipt of Fast Track designation represents a significant milestone for Insys and our clinical development of this novel drug-device combination.” He added, “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.”

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REGENXBIO Inc. shares were up 10.18% on Thursday with almost 780,000 shares traded, a small jump from the stock’s average trading volume of around 706,000 shares. The clinical-stage biotechnology company announced it is developing a new product candidate, RGX-181, for the treatment of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease. According to the company’s press release, this is one of the most common forms of Batten disease caused by mutations in the tripeptidyl peptidase 1 (TPP1) gene. “Our NAV technology platform holds tremendous promise for advancing this new product candidate in our neurodegenerative disease pipeline,” said Olivier Danos, Ph.D., who is the Senior Vice President and Chief Scientific Officer of the company. “CLN2 is a rapidly progressing, fatal disease with limited treatment options and no cure. Children with CLN2 disease experience an array of serious symptoms such as seizures, deterioration of language and motor skills, blindness, cognitive decline and premature death. The goal of our RGX-181 clinical program is to develop a single-dose treatment to halt progression of neurological decline and improve a broad range of these devastating symptoms experienced by children with CLN2 disease.”

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