(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) on Monday said it plans to start a Phase 2 study of TNX-2900 for the treatment of Prader-Willi syndrome, a genetic disorder that affects multiple parts of the body, in 2026.
The announcement follows clearance from the U.S. Food and Drug Administration (FDA) to advance the program into Phase 2.
The study will assess the safety, tolerability, and efficacy of TNX-2900 in male and female participants with Prader-Willi syndrome, aged 8 to 17.5 years.
TNX-2900 has received Orphan Drug and Rare Pediatric Disease designations from the FDA, making it eligible for a potential Priority Review Voucher upon approval.
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