08:12 AM EDT, 09/29/2025 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Monday it plans to begin a phase 2 study of its intranasal oxytocin drug TNX-2900 for Prader-Willi syndrome in 2026.

The biotechnology company said an investigational new drug application for TNX-2900 was cleared by the US Food and Drug Administration, allowing the program to progress into phase 2 development.

The randomized, double-blind, placebo-controlled trial will enroll patients ages 8 to 17.5 and track safety and efficacy over 12 weeks using the Hyperphagia Questionnaire as the primary endpoint, the company said.