Acasti Pharma reports Q3 EPS (9c) vs (9c) last year

Jan D’Alvise, Chief Executive Officer of Acasti, said "Significant progress was made over the past few months on all three of our clinical programs. We ended calendar 2022 in a very strong fashion with the completion of two successful clinical trials, and we announced important pharmacokinetic study results for both GTX-101 and GTX-102 in late December. In both cases, the preliminary topline results met all outcome measures. These positive results allow us to advance both programs to the next stage of clinical development in 2023. We expect 2023 to be very exciting for Acasti with two of our drug candidates ready to enter Phase 3. We look forward to receiving clarifying guidance from the FDA in calendar Q1 2023 on the Phase 3 study design for our lead program, GTX-104, a novel formulation of nimodipine for continuous IV infusion in patients suffering from subarachnoid hemorrhage. We are hopeful that this FDA feedback will confirm our 505(b)(2) regulatory strategy and allow us to finalize the study protocol, paving the way for the initiation of our Phase 3 safety study later this year."