Swedish pharmaceutical company Egetis Therapeutics AB (STO:EGTX) said on Friday that it has initiated a rolling New Drug Application submission to the U.S. Food and Drug Administration for Emcitate (tiratricol), an investigational treatment for MCT8 deficiency.

The FDA granted Breakthrough Therapy Designation to Emcitate in July 2025 and approved a rolling NDA submission and review in October 2025 based on available data.

Egetis has submitted the non-clinical and quality sections of the NDA following positive topline results from the ReTRIACt randomised controlled withdrawal study presented in November 2025. The company is finalising the clinical sections and plans to complete the NDA submission in early 2026, alongside a request for Priority Review, with a targeted FDA approval in the third quarter of 2026.

Emcitate has received multiple FDA designations, including Orphan Drug, Fast Track, Breakthrough Therapy, and Rare Pediatric Disease. Upon NDA approval, the drug is expected to be eligible for a Priority Review Voucher, subject to program timelines and potential legislative extension.