Acasti Pharma Announces Positive Results for Pharmacokinetic Bridging Study, With Intravenous GTX-104 Meeting All Endpoints

LAVAL, Québec, May 18, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) announced today that the top line results of its pharmacokinetic (PK) bridging study with IV GTX-104, the Company’s lead drug candidate for the treatment of Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The primary objective of the study was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy adult male and female subjects, while the secondary objective was to assess its safety and tolerability. The Company plans to submit these results to the US Food and Drug Administration (FDA), along with its proposed study design for the Phase 3 safety study which is on track to start in the second half of 2022. The safety study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting a New Drug Application to the FDA.

NewsGuest UserMay 26, 2022BIOOQuébecstudy report, FDA, quebec, innovation

Moderna Manufacturing Facility Opening in Montréal

Moderna announced on Friday that it had chosen Montréal as the location for its vaccine manufacturing facility. It will be able to produce 100 million doses per year and provide jobs for hundreds of specialized workers.

NewsGuest UserMay 24, 2022investment, Moderna, quebec

Health Canada initiates the review of the rolling submission for the first Canadian-based COVID-19 vaccine candidate

QUEBEC CITY, April 23, 2021 /CNW Telbec/ - Medicago, a biopharmaceutical company headquartered in Quebec City is pleased to announce that Health Canada received for review the first portion of Medicago's plant-derived adjuvanted COVID-19 vaccine candidate rolling submission on April 19, 2021.

NewsGuest UserApril 23, 2021COVID-19, Medicago, vaccine, submission, quebec

Biotechs in Québec

Biotechs base themselves on everyday life to find innovative solutions to various challenges to human health and well-being through the use of cutting-edge technology.