Coya Therapeutics Inc. has made significant progress in its regulatory journey with the U.S. Food and Drug Administration (FDA) regarding its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), COYA 302. Initially, the FDA had requested additional non-clinical data to support the initiation of a planned Phase 2 clinical study. In response, Coya Therapeutics re-submitted its Investigational New Drug $(IND.AU)$ Application on June 30, 2025, incorporating the requested data. The company is now awaiting acceptance of the IND, which will allow them to commence the Phase 2 study, aimed at evaluating the safety and efficacy of COYA 302. This development marks a crucial step forward in the company's efforts to advance potential treatment options for ALS.
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