Acasti Pharma (NASDAQ: NASDAQ:) has acquired a reaffirmation of its Purchase ranking and a $12.00 price goal from H.C. Wainwright.
The agency’s stance is available in mild of Acasti’s current announcement concerning the STRIVE-ON trial for GTX-104. The trial, which is investigating the intravenous nimodipine formulation’s security in treating aneurysmal subarachnoid hemorrhage (aSAH), has accomplished enrollment forward of schedule.
The biopharmaceutical firm reported the completion of enrollment for its pivotal security trial on Wednesday, with roughly 100 contributors enrolled. This marks a big acceleration from the 50% enrollment replace supplied in late June.
Out of the 25 activated websites, 23 have contributed to affected person recruitment. The final affected person follow-up is predicted to conclude by late December, with top-line information anticipated by February.
H.C. Wainwright tasks that Acasti Pharma may file a New Drug Utility (NDA) by June 2025, with potential FDA approval for GTX-104 by April 2026. This timeline assumes a normal 10-month evaluate, though a quicker 6-month precedence evaluate is feasible. The analyst agency believes that GTX-104 has the potential to turn into the brand new customary of look after aSAH within the ICU, in comparison with the present parenteral nimodipine remedy.
The forecast features a mid-calendar 2026 launch for GTX-104, with projected peak gross sales exceeding $130 million. These projections are based mostly on reasonable assumptions concerning the drug’s market penetration in the USA, the place up to 50,000 instances of aSAH happen yearly. Furthermore, the agency sees extra potential for the drug exterior the U.S. market, which has not been factored into its monetary mannequin.
H.C. Wainwright views the STRIVE-ON trial as a comparatively low-risk research when it comes to security when in comparison with oral nimodipine, given GTX-104’s product profile and former information.
The agency additionally considers the FDA approval course of to be of low danger, noting that previous approvals of nimodipine formulations for incremental administration enhancements in aSAH care set a precedent.
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