Galactosemia (G) is due to either partial or complete deficiency of the enzyme galactose-1-phosphate uridyl transferase (Ts). In females with G, there is a high incidence of premature ovarian failure.

The NDA for govorestat for the galactosemia indication was accepted by the FDA in late February under its Priority Review pathway. Year to date, shares of Applied Therapeutics have skyrocketed 155 ...

Looking for reliable medications to treat 'Galactosemia'? This page offers a detailed resource for the most up-to-date treatment options, including both generic and brand-name medications.

Applied Therapeutics' (APLT) lead drug candidate, govorestat, likely faces "significant" uncertainty in potentially treating galactosemia after the US Food and Drug Administration rejected the ...

Then, on December 2, 2024, Applied Therapeutics disclosed it received a "warning letter" from the FDA referring to the clinical trial issues underlying the CRL. Applied Therapeutics' common stock fell ...

In support of its New Drug Application (NDA) for govorestat for the treatment of galactosemia, Applied Therapeutics relied on data from its phase 3 ACTION-Galactosemia Kids trial in children ages ...