Shares of Applied Therapeutics (APLT +0.00%) 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.
NASDAQ: APLT
Key Data Points
Why the scrapped AdCom meeting is such good news for Applied Therapeutics
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.
Is Applied Therapeutics stock a buy?
Applied Therapeutics' big gains this year are warranted. The prospects for govorestat in treating galactosemia are promising. The company is also evaluating the drug in a late-stage clinical trial targeting sorbitol dehydrogenase (SORD) deficiency, another rare genetic metabolic disorder.
But is the healthcare stock still a good pick? I think so. The chances that Applied Therapeutics will win its first FDA approval within the next couple of months appear to be pretty good. A thumbs-up from the FDA would also probably increase investors' excitement about the potential for a follow-up approval in SORD deficiency.
