Life science investor Flerie AB (STO:FLERIE) announced on Tuesday that its portfolio company Egetis Therapeutics AB (STO:EGTX), a Swedish pharmaceutical company, has received US Food and Drug Administration approval for EMCITATE (tiratricol) to treat peripheral thyrotoxicosis in adult and paediatric patients with MCT8 deficiency.

EMCITATE is the first FDA-approved treatment for MCT8 deficiency, a rare, life-limiting X-linked disorder primarily affecting boys and men.

Egetis expects the drug to become commercially available in the United States within 8-10 weeks and has launched the Egetis RareLink patient support programme with PANTHERx Rare.

The FDA also granted Egetis a Rare Pediatric Disease Priority Review Voucher, which the company intends to evaluate for potential divestiture in the fourth quarter of 2026.

The approval was supported by a clinical development programme including the ReTRIACt, Triac Trial I and II, Erasmus Medical Center Cohort and Survival studies, and a US Expanded Access Program.

Flerie holds a 1% stake in Egetis Therapeutics.

MCT8 deficiency results from pathogenic mutations in the SLC16A2 gene that impair thyroid hormone transport, causing severe neurodevelopmental impairment and persistent peripheral thyrotoxicosis.