Why Applied Therapeutics Stock Is Skyrocketing Today

Shares of Applied Therapeutics (NASDAQ: APLT) had skyrocketed 70.5% as of 10:43 a.m. ET on Wednesday. The huge gain came after the U.S. Food and Drug Administration (FDA) told the company that an Advisory Committee meeting to review the New Drug Application (NDA) for govorestat in treating galactosemia, a rare genetic metabolic disease, was no longer required.Originally, the FDA tentatively planned to hold an Advisory Committee meeting to review the NDA for govorestat on Oct. 9, 2024. Now, though, the agency believes it can make an approval decision on the drug without bringing in outside experts. The FDA set a PDUFA date of Nov. 28, 2024, for this decision. Advisory Committee meetings increase the risk that a drug will not be approved. Although the FDA doesn't have to go along with the recommendations from these committees, it usually does. Now that the Advisory Committee meeting for govorestat has been canceled, the likelihood that the drug will win FDA approval should be greater.Continue readingWeiter zum vollständigen Artikel bei MotleyFool Weiter zum vollständigen Artikel bei MotleyFool