Acasti announces alignment with fda on gtx-104 pivotal phase 3 safety trial protocol and confirms planned initiation of strive-on in asah patients in calendar q4 2023

Strive-on is the pivotal phase 3 trial of gtx-104 to evaluate its comparable safety and tolerability profile relative to oral nimodipine in patients hospitalized with asah gtx-104 has been administered in over 150 healthy volunteers to-date and has demonstrated comparable safety profile to oral nimodipine company confirms its projected cash runway through a potential gtx-104 new drug application (nda) submission in the first half of calendar 2025 laval, qc , july 5, 2023 /prnewswire/ -- acasti pharma inc. ("acasti" or the "company") (nasdaq: acst), a late-stage, biopharma company advancing gtx-104, its novel injectable nimodipine formulation for intravenous infusion (iv) that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (asah), today announced that the company has aligned with the u.s. food and drug administration (fda) on the protocol for its pivotal phase 3 trial of gtx-104 and the fda also provided guidance for a potential gtx-104 new drug application (nda) package. acasti has all the necessary information from the fda to initiate its recently named strive-on (safety, tolerability, randomized, iv and oral nimodipine) pivotal phase 3 trial of gtx-104 to evaluate its safety and tolerability profile relative to oral nimodipine.
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