Acasti successfully submits pivotal gtx-104 phase 3 safety study protocol with fda and implements strategic realignment plan that extends projected cash runway through calendar q2 2025

Company successfully submits gtx-104 pivotal phase 3 protocol ind amendment to the fda with expectation for first patient dosed in calendar q4 2023 strategic realignment prioritizes gtx-104 and expects to extend cash runway through a potential new drug application (nda) filing for gtx-104 laval, quÉbec, may 8, 2023 /prnewswire/ -- acasti pharma inc. ("acasti" or the "company") (nasdaq: acst), a late-stage, biopharma company advancing gtx-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (asah), today announced the successful submission to the fda of gtx-104's full protocol of its pivotal phase 3 safety study and implementation of a strategic realignment plan to maximize shareholder value. prashant kohli, ceo of acasti, commented, "we are extremely pleased to execute on this important submission milestone as we advance gtx-104, a critically important drug candidate to the thousands of patients that suffer from subarachnoid hemorrhage without effective treatment options.
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