Acasti Pharma's GTX-104 Trial for aSAH Completes Enrollment Early, Eyes 2026 Launch
核心洞察
Acasti Pharma's STRIVE-ON trial, evaluating GTX-104 for aneurysmal subarachnoid hemorrhage (搜索) (aSAH (搜索)), 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.
Acasti Pharma (NASDAQ: ACST) is on track to potentially revolutionize the treatment of aneurysmal subarachnoid hemorrhage (搜索) (aSAH (搜索)) with its intravenous nimodipine formulation, GTX-104. The company recently announced the completion of enrollment for the STRIVE-ON trial, a pivotal safety study, significantly ahead of schedule. This progress has led H.C. Wainwright to reaffirm its Buy rating for Acasti Pharma, setting a price target of $12.00.
STRIVE-ON Trial Progress
The STRIVE-ON trial, designed to assess the safety of GTX-104 in treating aSAH (搜索), has enrolled approximately 100 participants across 23 of the 25 activated sites. This rapid enrollment marks a substantial acceleration from the 50% enrollment reported in late June. The last patient follow-up is anticipated by late December, with top-line data expected to be released by February.
Potential Regulatory Pathway and Market Opportunity
Based on the current timeline, H.C. Wainwright projects that Acasti Pharma could file a New Drug Application (NDA) by June 2025. Assuming a standard 10-month review process, the firm anticipates potential FDA approval for GTX-104 by April 2026. However, a faster 6-month priority review could expedite this timeline.
The analyst firm believes that GTX-104 has the potential to become the new standard of care for aSAH (搜索) in the ICU, offering an improved alternative to the current parenteral nimodipine treatment. The forecast includes a mid-calendar 2026 launch for GTX-104, with projected peak sales exceeding $130 million. These projections are based on moderate assumptions about the drug's market penetration in the United States, where up to 50,000 cases of aSAH occur annually. Moreover, the firm sees additional potential for the drug outside the U.S. market, which has not been factored into its financial model.
Safety and Approval Confidence
H.C. Wainwright views the STRIVE-ON trial as a relatively low-risk study in terms of safety when compared to oral nimodipine, given GTX-104's product profile and previous data. The firm also considers the FDA approval process to be of low risk, noting that past approvals of nimodipine formulations for incremental administration improvements in aSAH (搜索) care set a precedent.