Egetis Therapeutics Seeks US FDA Nod for MCT8 Deficiency Therapy

02:21 AM EST, 12/19/2025 (MT Newswires) -- Egetis Therapeutics (EGTX.ST) said Friday it submitted a rolling new drug application to the US Food and Drug Administration for its investigational MCT8 deficiency treatment Emcitate. The pharmaceutical company previously secured the regulator's breakthrough therapy designation for the drug in July, followed by a rolling new drug application submission and review in October. The application is backed by topline data from Egetis' randomized controlled withdrawal study ReTRIACt.