Egetis Therapeutics Wins FDA Approval for EMCITATE, First Treatment for MCT8 Deficiency

Egetis Therapeutics AB (EGTX.ST) said the U.S. Food and Drug Administration approved EMCITATE (tiratricol) for peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan-Herndon-Dudley syndrome. It is the first FDA-approved treatment for the X-linked disorder, which has a reported median life expectancy of about 35 years. The thyroid hormone receptor agonist was supported by trials including ReTRIACt, Triac Trial I and II, the Erasmus Medical Centre Cohort and Survival studies, and a U.S. Expanded Access Program. The FDA granted a Rare Pediatric Disease Priority Review Voucher, which Egetis may monetize as early as Q4 2026. EMCITATE is expected to launch in the U.S. in eight to ten weeks. Egetis ended Q2 with 378.4 million Swedish Kronor in cash. EGTX.ST closed Monday at 7.44 Kronor, down 5.58%.