NEW YORK, Dec. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") (NASDAQ: APLT). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Applied Therapeutics and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the clas ...

Key TakeawaysApplied Therapeutics' application for a treatment of a rare metabolic disease was rejected by the Food and Drug Administration.The FDA said the drug, govorestat for galactosemia, had "deficiencies in the clinical application."The news sent shares of Applied Therapeutics plunging 75% Friday morning. Applied Therapeutics (APLT) shares cratered Friday as the biopharmaceutical firm reported that the Food and Drug Administration (FDA) rejected its application for its experimental treatment for a rar ...

On Wednesday, Applied Therapeutics, Inc APLT received an FDA Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat for Classic Galactosemia.Galactosemia is a rare genetic metabolic disease resulting in an inability to metabolize the simple sugar galactose. When not appropriately metabolized, galactose is converted to the toxic metabolite, galactitol, which causes neurological complications.Also Read: Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Me ...

Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) seeking approval for APLT’s lead candidate, govorestat, to treat classic galactosemia. The CRL stated that the FDA has reviewed the application and cannot approve the NDA in its current form due to deficiencies in the clinical study results submitted in support of the application.Applied Therapeutics is evaluating the FDA's feedback. It intends to promptly request a meeting to di ...

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. The CRL indicates that the FDA completed its r ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ | --- | --- | |----------------------------------------------------------------------------|------------- ...

Exhibit 99.1 Applied Therapeutics Reports Third Quarter 2024 Financial Results - NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in Q1 2025 - NDA submission for govorestat for the treatment of SORD Deficiency under Accelerated Approval expected in early Q1 2025 NEW YORK, November 7, 2024 – Applied Therapeutics, Inc. (Nasdaq: APLT) (the "Company"), a clinical-stage biopharmaceut ...

Applied Therapeutics Inc. (APLT) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Has Applied Therapeutics Inc. (APLT) been one of those stocks this year? Let's take a closer look at the stock's year-to-date performance to find out.Applied Therapeutics Inc. is one of 1022 individual stocks in the Medical sector. Collectively, these companies sit at #4 in the Zacks Sector Rank. The Zacks Sector Rank considers 16 different sector groups. The average Zacks R ...

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Applied Therapeutics Inc. (APLT) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Applied Therapeutics Inc. is a member of the Medical sector. This group includes 102 ...