Acasti Pharma Inc ACST

Healthcare

Acasti Pharma Inc. is a Canada-based late-stage biopharma company with drug candidates addressing rare and orphan diseases. The Company is targeting three underserved orphan diseases: GTX-104, an intravenous infusion targeting subarachnoid hemorrhage (SAH), a rare and life-threatening medical emergency, in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull; GTX-102, an oral mucosal spray targeting ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily impacts children causing severe disability; and GTX-101, a topical spray, targeting postherpetic neuralgia, a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles). The Company’s clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection.

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Acasti Pharma Inc > Meeting with FDA to Discuss Results

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Post by Canadian_101on Mar 11, 2020 10:00am

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Meeting with FDA to Discuss Results

Jan D’Alvise, president and CEO of Acasti Pharma, commented, “We have completed the clinical site and central lab audits of the TRILOGY 1 data, including additional post-hoc analyses. As a result, I am pleased to report that we now expect to submit our FDA meeting request by the end of March. We look forward to reporting further developments, including an update on a meeting date as soon as it has been set.”

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