ACASTI PHARMA INC

Acasti Pharma Inc. rebrands to Grace Therapeutics, Inc., trading on Nasdaq as 'GRCE' from Oct 28, 2024. The company focuses on GTx-104, an injectable nimodipine for aneurysmal subarachnoid hemorrhage (aSAH), with a $300M U.S. market potential. A Key Opinion Leader event on GTx-104 is scheduled for Nov 20, 2024.

Acasti Pharma completes patient enrollment in Phase 3 STRIVE-ON trial for GTX-104, an injectable nimodipine for aSAH, with data readout expected early 2025 and NDA submission planned for 1H 2025.

Acasti Pharma's Buy rating and $12.00 price target are reaffirmed by H.C. Wainwright due to the STRIVE-ON trial's early enrollment completion for GTX-104, targeting aSAH treatment. The trial's last follow-up is expected by December, with data anticipated in February. H.C. Wainwright projects a potential NDA filing by June 2025 and FDA approval by April 2026, with peak sales forecasted at over $130 million, based on U.S. aSAH cases.

Acasti Pharma Inc. completed patient enrollment in its Phase 3 STRIVE-ON safety trial for GTX-104, an injectable nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). The trial, involving 100 patients across 25 U.S. hospitals, compares GTX-104 with oral nimodipine. Acasti anticipates trial data in early 2025 and plans to submit a New Drug Application to the FDA in the first half of 2025.

KUR International appoints John Giammona, PhD, as President and Chief Commercial Officer to lead strategic and operational direction of clinical research, biobank, and diagnostics services groups, marking a significant milestone in the company's expansion and commercial endeavors.