Clinical Trials
8
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
12.5%
Completed
5
62.5%
Unknown
2
25.0%
No approval data available
- Acasti Pharma's STRIVE-ON trial, evaluating GTX-104 for aneurysmal subarachnoid hemorrhage (aSAH), has completed enrollment ahead of schedule with approximately 100 participants. - Top-line data from the pivotal safety trial is expected by February, potentially leading to a New Drug Application (NDA) filing by June 2025. - H.C. Wainwright maintains a Buy rating for Acasti Pharma, projecting peak sales for GTX-104 to exceed $130 million, with potential FDA approval by April 2026. - GTX-104 is poised to become the new standard of care for aSAH in the ICU, given its product profile and previous data.
- Acasti Pharma has completed patient enrollment in its Phase 3 STRIVE-ON trial evaluating GTX-104 for aneurysmal subarachnoid hemorrhage (aSAH). - The STRIVE-ON trial is comparing intravenous GTX-104 to oral nimodipine in 100 patients hospitalized with aSAH across 25 U.S. hospitals. - GTX-104, an injectable formulation of nimodipine, aims to address challenges associated with oral administration and improve patient outcomes. - Acasti anticipates STRIVE-ON data readout in early 2025 and plans to submit an NDA to the FDA in the first half of 2025.
