Wait for Galactosemia Therapy Goes on After FDA Shuns Applied Therapeutics' Govorestat

Yahoo FinanceNov 28 07:02 ET

Outlook OTLK -65% Phase 3 Fail; Applied Therapeutics APLT Halted AH CRL

BioPharmCatalystNov 27 18:31 ET

Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat For Classic Galactosemia

BenzingaNov 27 16:11 ET

FDA rejected the drug Applied Therapeutics in a complete response letter, causing a 78% plunge in after-hours trading.

On Wednesday, $applied therapeutics(APLT.us)$ plummeted by 78% after hours to $1.89. On the news front, the US FDA has rejected the company's application for govorestat to treat the rare metabolic disease classic galactosemia. In a comprehensive response letter, the FDA stated that due to deficiencies in the application, it could not approve the drug. The company stated it is reviewing the FDA's feedback and will request a meeting with the institutions to discuss the necessary conditions for a potential resubmission. Govorestat is currently targeting sorbitol dehydrogenase.

Zhitong FinanceNov 27 18:28 ET

Trending Stocks Today | Biomerica Surges 36.1% Post-Market

Moomoo NewsNov 27 18:00 ET

Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter

WSJNov 27 17:33 ET