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0 0 0.00877192982456141 0.00877192982456141 -0.00877192982456141 0.0064473684210526 0.013157894736842 0.0132456140350876
Stock impact report

Acasti Pharma Announces Initiation of Pharmacokinetic Bridging Study for GTX-104, the Company's Lead Drug Candidate for the Treatment of Subarachnoid Hemorrhage [Financial Post (Toronto, O...

Acasti Pharma, Inc. - Class A (ACST) 
Last acasti pharma, inc. - class a earnings: 2/14 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: acastipharma.com/investors
Company Research Source: Financial Post
Article content LAVAL, Québec, Sept. 27, 2021 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announces the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of intravenous (IV) GTX-104 compared to currently marketed oral nimodipine capsules in 50 healthy subjects. The PK study is the next required step in the proposed 505(b)(2) regulatory pathway for GTX-104. Results from this study are expected in the first half of calendar 2022, and after review with the U.S. Food & Drug Administration (FDA), will help to determine the final design of the Company's planned Phase 3 safety study for GTX-104 in Subarachnoid Hemorrhage (SAH) patients. Assuming the PK study and related FDA review progress as planned, the Company expects to begin the Phase 3 study during the second half of 2022. GTX-104 is a novel IV nimodipine infusion being developed to treat SAH, which is a central nervous Show less Read more
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