AT-001

DelveInsight's report on Congestive Heart Failure Market (2020-2034) covers epidemiology, market trends, key companies, and therapies. Market size was ~USD 6,900 million in 2023, expected to grow significantly. Key companies include Novartis, Bayer, and Eli Lilly. Therapies like ENTRESTO and JARDIANCE are highlighted. Market drivers include aging population and disease prevalence, while barriers include generic therapies and diagnostic challenges.

Applied Therapeutics announced progress on its NDA for govorestat, a treatment for Classic Galactosemia, following a late-cycle review with the FDA. The FDA confirmed no Advisory Committee meeting is needed, maintaining the PDUFA target action date of November 28, 2024. Govorestat has shown clinical benefits in reducing toxic metabolite levels and improving patient outcomes.

Applied Therapeutics updated on govorestat's NDA review for Classic Galactosemia treatment. FDA canceled the Advisory Committee meeting, continuing Priority Review with a PDUFA target action date of November 28, 2024. Govorestat, a CNS penetrant ARI, showed clinical benefits in Galactosemia and SORD Deficiency trials.

Applied Therapeutics announced the FDA extended the review period for govorestat (AT-007) NDA for Classic Galactosemia treatment to November 28, 2024, due to a Major Amendment. Govorestat, an Aldose Reductase Inhibitor, shows promise in treating Galactosemia, with clinical benefits and safety profile. The company also submitted an MAA to the EMA, expecting a decision by Q4 2024.

Applied Therapeutics announced FDA acceptance of govorestat's NDA for Galactosemia treatment, granting Priority Review with a PDUFA date of August 28, 2024. Govorestat, an Aldose Reductase Inhibitor, shows promise in reducing galactitol and improving clinical outcomes in Galactosemia patients, potentially becoming the first approved treatment.

Applied Therapeutics plans a Pre-NDA meeting with the FDA this summer for govorestat (AT-007) to treat Classic Galactosemia, aiming for an NDA submission in fall. An EMA Marketing Authorization Application is also planned for fall 2023. Govorestat shows promise with clinical efficacy and safety for Galactosemia, a rare metabolic disease.