Applied Therapeutics Inc

Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company which engages in the development of a pipeline of novel products. It is targeting treatments for central nervous system rare diseases and diabetic complications. The company was founded by Shoshana Shendelman on January 20, 2016 and is headquartered in New York, NY.

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Boston, Massachusetts--(Newsfile Corp. - January 4, 2022) -  Berman Tabacco, a national law firm representing investors, is investigating potential securities law violations by Applied Therapeutics, Inc. ("AT" or the "Company") (NASDAQ: APLT), a clinical-stage biopharmaceutical company with headquarters in New York, New York.On January 3, 2022, before the market opened, the Company issued a press release providing a regulatory update on the Company's AT-007 Galactosemia program. The Company stated, among other things, that "[f]ollowing...

Berman Tabacco Announces Investigation of Applied Therapeutics, Inc. (APLT) for Potential Securities Law Violations

The company's lead candidate, AT-007, is going to take a lot longer to reach patients than expected.

Why Applied Therapeutics Stock Is Sliding Today

Applied Therapeutics (NASDAQ: APLT) is trading significantly lower Monday after the company said it would not immediately submit a new drug application for its AT-007 for treatment of galactosemia. The Galactosemia program had previously been discussed in the context of an NDA for accelerated approval based on reduction in galactitol, but the FDA has now indicated that clinical outcomes data will likely be required for approval.

Why Applied Therapeutics Shares Are Falling Today

Following discussions with the FDA, Applied Therapeutics Inc (NASDAQ: APLT) has decided to hold on submitting a marketing application for AT-007 for Galactosemia pending additional talks with the agency.  Although the Galactosemia program had previously been discussed for Accelerated Approval based on reduction in galactitol, the FDA has now indicated that clinical outcomes data will likely be required for approval.

Applied Therapeutics To Hold Filing FDA Application For AT-007 In Rare Metabolic Disorder

NEW YORK, Jan. 03, 2022 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today provided a regulatory update on the AT-007 Galactosemia program.

Applied Therapeutics Provides Regulatory Update on Galactosemia Program

NEW YORK, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the initiation of a registrational phase 2/3 study of AT-007 in Sorbitol Dehydrogenase (SORD) Deficiency. The study, termed INSPIRE (INhibition of Sorbitol Production through Inhibition of the Aldose Reductase Enzyme), will investigate biomarker efficacy, clinical outcomes and safety in people living with SORD Deficiency treated with AT-007 vs. placebo.

Applied Therapeutics Announces Initiation of Registrational Phase 2/3 Study of AT-007 in SORD Deficiency

NEW YORK, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, has announced a symposium and poster presentations at the 14th International Congress of Inborn Errors of Metabolism (ICIEM), November 21-23, 2021, Sydney, Australia.

Applied Therapeutics to Present at the 14th International Congress of Inborn Errors of Metabolism

Data from pilot trial of AT-007 in SORD deficiency expresses substantial and significant reduction in sorbitol

Applied Therapeutics Reports Third Quarter 2021 Financial Results

Substantial and statistically significant reduction in plasma galactitol of 40% with new weight-based dosing parameters

Applied Therapeutics Reports Additional Pediatric Biomarker Data from ACTION-Galactosemia Kids

Applied Therapeutics Inc. (APLT) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Applied Therapeutics Inc. (APLT) Upgraded to Buy: Here's Why

Applied Therapeutics Inc (NASDAQ: APLT) has reported initial biomarker data from the pediatric ACTION-Galactosemia Kids study and baseline analysis of the 47 children enrolled in the study. Related Content:   FDA Fast Track Review For AT-007 In Rare Metabolic Disorder.

Applied Therapeutics Stock Drops On Delayed NDA Submission For Its Lead Candidate

NDA submission for AT-007 in Galactosemia expected in Q3 2021; commercial preparations ongoing

Applied Therapeutics Reports Second Quarter 2021 Financial Results

NEW YORK, June 28, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the Company has joined the Russell Microcap® Index. The newly reconstituted index took effect after the market close on Friday, June 25, 2021.

Applied Therapeutics Added to Russell Microcap® Index

~1 in 5 people with diabetes or pre-diabetes have Diabetic Cardiomyopathy, a serious and progressive disease that limits the heart's ability to function   People with diabetes or pre-diabetes who have Diabetic Cardiomyopathy are at high risk for developing overt heart failure

Applied Therapeutics Announces Presentation of Data on the Prevalence of Diabetic Cardiomyopathy at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association

NEW YORK, June 21, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced a Product Theater presentation at the upcoming 81st Scientific Sessions of the annual 2021 American Diabetes Association meeting taking place virtually June 25-29. The Product Theater will include an overview of Diabetic Cardiomyopathy (DbCM), the increased risk of progression to overt heart failure and death due to the disease, new data on the wide prevalence of the disease among patients with diabetes, the role of aldose reductase in the pathogenesis of disease, and a review of the ongoing ARISE-HF global registrational trial of AT-001, a novel and selective aldose reductase inhibitor.

Applied Therapeutics to Present on Diabetic Cardiomyopathy and Prevalence of Disease at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association

The FDA has granted Fast Track designation to Applied Therapeutics Inc's (NASDAQ: APLT) AT-007 to treat Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders.

Applied Therapeutics Stock Moves Higher On FDA Fast Track Review For AT-007 In Rare Metabolic Disorder

NEW YORK, June 17, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AT-007 for the treatment of Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders, including Galactosemia, SORD and PMM2-CDG.

Applied Therapeutics Granted Fast Track Designation by FDA for AT-007 for Galactosemia

NEW YORK, June 01, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 1:20 p.m. ET.

Applied Therapeutics to Present at the Goldman Sachs 42nd Annual Global Healthcare Conference

NEW YORK, May 19, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today that it will present at the UBS Global Healthcare Virtual Conference on Tuesday, May 25, 2021 at 10:00 a.m. ET.

Applied Therapeutics to Present at the UBS Global Healthcare Virtual Conference

Phase 2 pilot study of AT-007 initiated in patients with SORD Deficiency

Applied Therapeutics Reports First Quarter 2021 Financial Results

AT-007 ACTION-Galactosemia Kids pediatric clinical study recently resumed following discussions with FDA

Applied Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results

NEW YORK, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today that it will present at two upcoming investor conferences in March:

Applied Therapeutics to Present at the Cowen and Barclays Investor Conferences

NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the closing of its public offering of 3,000,000 shares of its common stock, par value $0.0001 per share.  The shares were offered at a price to the public of $23.00 per share, resulting in aggregate net proceeds of approximately $64.6 million, after deducting underwriting discounts and commissions and estimated offering expenses.  The offering closed on February 17, 2021.  The Company granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock at the price to the public, less underwriting discounts and commissions, which the underwriters exercised in full on February 17, 2021 and settled on February 19, 2021.

Applied Therapeutics, Inc. Announces Closing of Public Offering

Applied Therapeutics Inc (NASDAQ: APLT) prices its underwritten public offering of 3 million at $23 per share, raising $69 million in gross proceeds, at a marginal premium of 2%. Underwriters have an option to purchase up to 450,000 additional shares.

Applied Therapeutics Raises $69M Via Equity

NEW YORK, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the pricing of its underwritten public offering of 3,000,000 shares of its common stock, par value $0.0001 per share, at a price to the public of $23.00 per share. The gross proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, are expected to be $69 million. The Company has granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock at the price to the public, less underwriting discounts and commissions.

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