24/7 Market News Snapshot 18 September, 2024 – Applied Therapeutics, Inc. Common Stock (NASDAQ:APLT)

September 18, 2024

DENVER, Colo., 18 September, 2024 (247marketnews.com) – (Nasdaq:APLT) are discussed in this article.
Applied Therapeutics, Inc. (Nasdaq:APLT) is experiencing significant momentum, reflected in a noteworthy pre-market trading increase, with shares surging by 22.67% to reach $5.704. This rise is accompanied by a substantial volume of 1.11 million shares, signaling heightened investor confidence and interest, which may suggest continued upward potential as the trading day progresses.

In a recent strategic update, the company reported a promising advancement regarding its New Drug Application (NDA) for govorestat, specifically designed to treat Classic Galactosemia. Following a late-cycle review meeting, the FDA has confirmed it will not hold an Advisory Committee meeting for the application, marking a positive step and indicating an ongoing productive relationship between the agency and the company. The FDA’s Priority Review of the NDA is on track, with post-marketing discussions scheduled for October and a PDUFA target action date set for November 28, 2024.

Dr. Shoshana Shendelman, the Founder and CEO of Applied Therapeutics, expressed optimism regarding the collaborative dialogue with the FDA during the NDA process, underscoring the potential transformative impact of govorestat for patients suffering from Classic Galactosemia, a rare genetic disorder that severely affects the metabolism of galactose, leading to dire neurological implications. Govorestat is an innovative Aldose Reductase Inhibitor that has yielded encouraging results in clinical trials, showing promise in reducing harmful plasma levels of galactitol in affected children.

With an estimated 3,000 patients diagnosed with Classic Galactosemia in the U.S. alone, Applied Therapeutics is dedicated to ensuring access to effective treatment options. The company’s focused efforts in commercial preparations aim to enhance patient and physician engagement, demonstrating a strong commitment to addressing significant medical needs within this underserved community. As the situation evolves, Applied Therapeutics remains resolute in its mission to provide innovative therapies that improve the lives of patients and their families.

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