Applied Therapeutics (APLT) Stock

The U.S. Food and Drug Administration on Wednesday declined to approve Applied Therapeutics' drug to treat galactosemia, a rare genetic metabolic disease, the company said.

NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia.

Applied Therapeutics (APLT) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Here is how Applied Therapeutics Inc. (APLT) and Cardinal Health (CAH) have performed compared to their sector so far this year.

Applied Therapeutics (APLT) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Applied Therapeutics, Inc.'s stock surged nearly 70% yesterday after the news that the FDA will not hold an AdCom to discuss approval of AT-007 in galactosemia. AT-007 has shown clinical benefits in galactosemia and SORD deficiency, and its PDUFA for the former arrives at the end of November. With no AdCom, approval seems the likeliest outcome. Despite financial constraints, strong patient and HCP support suggest a successful commercial launch for govorestat, making Applied stock a “Buy” with expected valuation growth.

Applied Therapeutics stock surges 69% as the FDA says that no advisory committee meeting is required to discuss the govorestat NDA for classic galactosemia.

FDA removes the need for an advisory panel to first give a recommendation review of Applied Therapeutics, Inc.'s govorestat for the treatment of patients with galactosemia. PDUFA date of November 28th, 2024, remains on track for the FDA to decide whether govorestat should be approved to treat patients with galactosemia. Pre-NDA meeting with FDA expected in 2nd half of 2024 to discuss possible administrative actions of NDA filing submission of govorestat for the treatment of patients with SORD deficiency.

William Blair initiated coverage on Applied Therapeutics Inc. APLT, a late-stage development company focused on rare diseases such as galactosemia, SORD deficiency, and diabetic cardiomyopathy.