Acasti Pharma doses first patient in GTX-104 STRIVE-ON trial

Acasti Pharma announced enrollment of the first patient in the Company’s pivotal Phase 3 STRIVE-ON safety trial. UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial. The Company previously announced alignment with the U.S. Food and Drug Administration on the protocol and dosing regimen for the STRIVE-ON trial, at which time the FDA provided guidance regarding a potential New Drug Application submission for GTX-104, currently anticipated in the first half of calendar 2025. GTX-104 has already been administered in over 160 healthy subjects in prior Phase 1 trials and has a well-established safety profile. GTX-104 has the potential to disrupt the oral nimodipine dosage form and become the standard of care in aSAH patients addressing critical unmet medical needs. Acasti also recently hosted a virtual key opinion leader event featuring W. Taylor Kimberly, MD, PhD who discussed the high unmet medical need and current treatment landscape for patients suffering from aSAH.