Acasti Pharma (NASDAQ: NASDAQ:ACST) has received a reaffirmation of its Buy rating and a $12.00 price target from H.C. Wainwright.
The firm's stance comes in light of Acasti's recent announcement regarding the STRIVE-ON trial for GTX-104. The trial, which is investigating the intravenous nimodipine formulation's safety in treating aneurysmal subarachnoid hemorrhage (aSAH), has completed enrollment ahead of schedule.
The biopharmaceutical company reported the completion of enrollment for its pivotal safety trial on Wednesday, with approximately 100 participants enrolled. This marks a significant acceleration from the 50% enrollment update provided in late June.
Out of the 25 activated sites, 23 have contributed to patient recruitment. The last patient follow-up is expected to conclude by late December, with top-line data anticipated by February.
H.C. Wainwright projects that Acasti Pharma could file a New Drug Application (NDA) by June 2025, with potential FDA approval for GTX-104 by April 2026. This timeline assumes a standard 10-month review, although a faster 6-month priority review is possible. The analyst firm believes that GTX-104 has the potential to become the new standard of care for aSAH in the ICU, compared 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.
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 care set a precedent.
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