“During the past year we continued to execute our focused strategy around our biggest value driver program GTX-104 and its pivotal Phase 3 STRIVE-ON safety trial,” said Prashant Kohli, CEO of Acasti. “Since initiating STRIVE-ON and dosing the first patient last October, enrollment has proceeded steadily, and we believe the trial is on track for a potential NDA submission to the FDA in the first half of calendar 2025. With our balance sheet enhanced by the $7.5 million private placement secured in September 2023, and disciplined execution of the strategic realignment plan we announced in May 2023, our cash runway is expected to extend into the second calendar quarter of 2026, well beyond our planned submission of the GTX-104 NDA.”
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