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NDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term...
Pre-NDA Meeting to be held with FDA this summer to discuss potential NDA submission for govorestat for treatment of Classic Galactosemia EMA Marketing Authorization Application for govorestat for...
EMA Orphan Designation reflects high unmet need in SORD Deficiency and benefit of govorestat treatment in reducing toxic sorbitol levelsNew data published in Journal of Clinical Investigation further... | May 25, 2023
Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker dataGovorestat treatment... | June 18, 2023
PDF Version Company plans to strengthen its manufacturing capacity, R&D, ecosystem partnerships and workforce development in Singapore ... | December 23, 2022