Why Applied Therapeutics Stock Is Soaring Today

Actions of Applied therapeutics (APLT 68.39%) skyrocketed 70.5% as of 10:43 a.m. ET Wednesday. The huge win came after the US Food and Drug Administration (FDA) told the company that an Advisory Committee meeting is no longer necessary to review the New Drug Application (NDA) for govorestat in the treatment of galactosemia, a rare genetic metabolic disease.

The FDA initially tentatively planned to hold an advisory committee meeting to review the NDA for govorestat on October 9, 2024. Now, however, the agency believes it can make a decision to approve the drug without bringing in outside experts. FDA has set a PDUFA date of November 28, 2024 for this decision.

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 is not required to follow the recommendations of these committees, it usually does. Now that the Govorestat Advisory Committee meeting has been canceled, the likelihood of the drug winning FDA approval should be higher.

Is Applied Therapeutics Stock a Buy?

Applied Therapeutics’ big gains this year are guaranteed. The outlook for govorestat in the treatment of galactosemia is promising. The company is also evaluating the drug in a late-stage clinical trial targeting sorbitol dehydrogenase deficiency (SORD), another rare genetic metabolic disorder.

But is healthcare stock still a good pick? I think so. The odds of Applied Therapeutics winning its first FDA approval in the next couple of months seem pretty good. An approval from the FDA would likely increase investor excitement about the potential for further approval in the SORD deficiency.