Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Applied Therapeutics regarding the New Drug Application (NDA) for govorestat for the treatment of classic ...

Pomerantz LLP is investigating claims on behalf of investors of Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") . Such investors are advised to contact Danielle Peyton at ...

Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...

The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...

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

Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...

RBC Capital Markets downgraded Applied Therapeutics Inc (NASDAQ:APLT) stock to "sector perform" from "outperform” citing ...

This sharp decline in the company’s stock raises several questions about its future prospects, especially given the positive momentum it had been building throughout the year. Let’s delve into what ...

Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...

FDA rejected Applied Therapeutics' Govorestat for galactosemia, citing NDA deficiencies. The company plans discussions for ...