Zynerba Pharmaceuticals (ZYNE)

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Zygel in Developmental and Epileptic Encephalopathies (DEE)
Meeting with U.S. Food and Drug Administration (FDA) to Discuss Pathway for Zygel in DEE Expected in the First Half of 2020
Zynerba expects to meet with the FDA to discuss the clinical path forward in DEE. Based on the Phase 2 trial design and positive efficacy and safety results, Zynerba anticipates that it will discuss the pursuit of an indication that includes all syndromes and encephalopathies in the DEE category that present with focal impaired-awareness seizures (FIAS; previously known as complex partial seizures) and/or convulsive seizures (CS), the most common and debilitating seizure types representing 75% to 80% of all seizures.
Corporate
Enhanced Senior Management Team
Paul M. Kirsch joined Zynerba as Vice President of Regulatory Affairs and Quality Assurance, bringing 30 years of regulatory affairs management experience with companies including Trevena, Inc., Iroko Pharmaceuticals, LLC, Teva Pharmaceuticals, and Cephalon, Inc. He has extensive regulatory experience with orphan and neuroscience products, and has led five successful NDAs into commercialization in multiple indications.