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-0.00381679389312969 0.00127226463104334 -0.0165394402035623 -0.00513994910941476 -0.0369083969465649 -0.0209923664122137 -0.0127226463104325 -0.0319083969465649
Stock impact report

Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug [Yahoo! Finance]

Applied Therapeutics, Inc. (APLT) 
Last applied therapeutics, inc. earnings: 11/13 07:00 am Check Earnings Report
Company Research Source: Yahoo! Finance
a session volume of 31.75 million, compared to an average volume of 1.26 million, according to data from Benzinga Pro The company announced an update on the ongoing New Drug Application (NDA) review of govorestat for Classic Galactosemia Galactosemia is an inherited metabolic disorder that makes the body unable to process a sugar called galactose. The company recently completed its late-cycle review meeting with the FDA, and the agency communicated that an Advisory Committee meeting, previously tentatively scheduled for October 9, would no longer be required. The FDA informed the company that the Priority Review of the NDA is continuing as planned, with alignment on post-marketing requirements expected in October 2024. The previously announced Prescription Drug User Fee Act (PDUFA) target action date remains on track for November 28. In April, the FDA extended the review period for Applied Therapeutics' marketing application, seeking approval for its potentially first mark Show less Read more
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