Diabetic cardiomyopathy

Applied Therapeutics Reports First Quarter 2024 Financial Results

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Giovedì, Maggio 9, 2024
Sale, FDA, PRV, American College, Diabetic cardiomyopathy, Investment, Priority review, ACC, NDA, Food, Research, Marketing, New Drug Application, MAA, CHMP, Doctor of Philosophy, Disease, Journal, ChromeOS, PDUFA, Patient, Treatment, EMA, JACC, Therapy, HF, European Medicines Agency, Ageing, Pharmaceutical industry

As a result, the Company now expects a decision by the EMA in early first quarter of 2025.

Key Points: 
  • As a result, the Company now expects a decision by the EMA in early first quarter of 2025.
  • Mr. Hooks brings over 30 years of biopharmaceutical experience in leadership, rare disease marketing and sales roles to Applied Therapeutics.
  • Presented Full Results from Phase 3 ARISE-HF Study of AT-001 (caficrestat) in Diabetic Cardiomyopathy at the 2024 American College of Cardiology Annual Scientific Session.
  • Following the presentation, the full study results were published in the Journal of the American College of Cardiology (JACC).

Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024

Retrieved on: 
Giovedì, Aprile 4, 2024
Diabetic cardiomyopathy, Patient, Journal, Diabetes, American College, Treatment, Therapy, Safety, ACC, JACC, Pharmaceutical industry

The presentation at ACC will also include important data on progression to overt heart failure and other secondary outcome measures.

Key Points: 
  • The presentation at ACC will also include important data on progression to overt heart failure and other secondary outcome measures.
  • AT-001 treatment prevented progression to overt heart failure in patients with DbCM as compared to placebo (p=0.0285).
  • The oral presentation at ACC will be followed by simultaneous publication of the study results in the Journal of the American College of Cardiology Journal (JACC).
  • A Selective Aldose Reductase Inhibitor (AT-001) For the Treatment of Diabetic Cardiomyopathy: Primary Results of the Phase 3 Randomized Controlled ARISE-HF Study
    Monday, April 8, 2024, 8:30 – 9:45 am ET, Main Tent (Hall B1)

Journal of Pharmaceutical Analysis Articles Provide Novel Insights into Previously Unknown Disease Mechanisms

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Martedì, Febbraio 27, 2024
Nerve, Central nervous system, Metabolism, PXR, Alzheimer's disease, Testosterone, PCN, Research, MSI, Diabetic cardiomyopathy, Inflammation, Pathology, Deficit spending, Pregnane X receptor, MALDI, Neurotoxicity, Dysbiosis, JPA, Hippocampus, CYP, Heart failure, DCM, Domestic airport, Phenytoin, Mass spectrometry, PHT, Triglyceride, TMAO, Transplant, Glucocorticoid, Lipid metabolism, Patient, Journal, Glucose, Heart, Mouse, Glycated hemoglobin, Brain

XI'AN, China, Feb. 27, 2024 /PRNewswire/ -- DCM is the leading cause of heart failure in patients with chronic diabetes, with unclear mechanisms and limited treatments. Another mystery is the regulation of cytochrome P450 enzymes (CYPs) in the central nervous system. Moreover, the link between the gut microbiome, microbiota-derived metabolites, and the progression of AD remains unknown. In the December issue of Journal of Pharmaceutical Analysis (JPA), three articles explore the interconnected pathologies of DCM, hippocampal neurotoxicity, and AD, offering a comprehensive insight.

Key Points: 
  • Moreover, the link between the gut microbiome, microbiota-derived metabolites, and the progression of AD remains unknown.
  • In the December issue of Journal of Pharmaceutical Analysis (JPA), three articles explore the interconnected pathologies of DCM, hippocampal neurotoxicity, and AD, offering a comprehensive insight.
  • Their findings, available online on 17 August 2023, were published in Volume 13, Issue 12 of the journal in December 2023.
  • Gut dysbiosis aggravates cognitive deficits, amyloid pathology and lipid metabolism dysregulation in a transgenic mouse model of Alzheimer's disease

Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy

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Giovedì, Gennaio 4, 2024
Cardiology, Hospital, Food, Survival, BID, Physician, FDA, EMA, MAA, Diabetes, Disease, Massachusetts General Hospital, NDA, Incidence, MD, Doctor of Philosophy, Therapy, Odds ratio, Diabetic cardiomyopathy, New Drug Application, European Medicines Agency, SGLT2, Patient, Safety, Galactosemia, Heart failure, Pharmaceutical industry

NEW YORK, Jan. 04, 2024 (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 topline results of the ARISE-HF Phase 3 trial of AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM) at high risk of progression to overt heart failure.  

Key Points: 
  • While a trend favored active treatment, the difference between active and placebo treated groups (0.30 ml/kg/min) was not statistically significant (p=0.210).
  • The ARISE-HF study evaluated the treatment effect of AT-001 as an add-on to diabetes standard of care therapies.
  • Approximately 38% of study subjects were on SGLT2 or GLP-1 therapies for treatment of diabetes, while 62% were not.
  • Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.

Applied Therapeutics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Giovedì, Novembre 9, 2023
Massachusetts General Hospital, FDA, Research, Insurance, Harvard Medical School, Heart failure, MAA, Ongo, Treatment, MD, Cardiology, European Medicines Agency, Diabetes, Chairperson, Doctor of Philosophy, ChromeOS, EASD, Quality of life, Symposium, KOL, U.S. FDA, EMA, European Association for the Study of Diabetes, Annual general meeting, NDA, Safety, Therapy, Diabetic cardiomyopathy, Investment, Patient, Advanz Pharma, Pharmaceutical industry, Birth control, SORD, Galactosemia

NEW YORK, Nov. 09, 2023 (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 reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics, presented the data in an oral Symposium entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes.
  • Cash and cash equivalents and short-term investments totaled $37.5 million as of September 30, 2023, compared with $30.6 million at December 31, 2022.
  • Net loss for the third quarter of 2023 was $42.4 million, or $0.47 per basic and diluted common share, compared to a net loss of $19.1 million, or $0.40 per basic and diluted common share, for the third quarter 2022.

Applied Therapeutics to Host Diabetic Cardiomyopathy Expert Forum with Key Opinion Leaders on Tuesday, November 7

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Mercoledì, Novembre 1, 2023
Massachusetts General Hospital, Research, Centre for Applied Genomics, Harvard Medical School, Heart failure, MD, Cardiology, Webcast, Therapy, Diabetic cardiomyopathy, Pharmaceutical industry, Broadcasting, Medical device

NEW YORK, Nov. 01, 2023 (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 it will host a Diabetic Cardiomyopathy (DbCM) expert forum with key opinion leaders on Tuesday, November 7, 2023 at 8:00 a.m. ET.

Key Points: 
  • NEW YORK, Nov. 01, 2023 (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 it will host a Diabetic Cardiomyopathy (DbCM) expert forum with key opinion leaders on Tuesday, November 7, 2023 at 8:00 a.m.
  • ET.
  • Webcast information for this event will be accessible on the Events page under the Investor Relations section of the Applied Therapeutics website at www.appliedtherapeutics.com.
  • A replay of the webcast will be archived on the Company’s website following the forum.

Applied Therapeutics to Present Baseline Data from Phase 3 ARISE-HF Study Evaluating AT-001 at the 2023 EASD Annual Meeting

Retrieved on: 
Giovedì, Settembre 28, 2023
Heart failure, Diabetes, Diabetic cardiomyopathy, Center for Applied Genomics, European Association for the Study of Diabetes, Doctor of Philosophy, EASD, MD, Patient, Risk, Symposium, Annual general meeting, Therapy, Disease, Pharmaceutical industry

NEW YORK, Sept. 28, 2023 (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 it will participate in a Symposium presentation, entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes, at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting to take place October 2-6, 2023 in Hamburg, Germany and online.

Key Points: 
  • NEW YORK, Sept. 28, 2023 (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 it will participate in a Symposium presentation, entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes, at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting to take place October 2-6, 2023 in Hamburg, Germany and online.
  • “Patients with diabetes are at a high risk of developing overt heart failure even when optimal glucose control is achieved,” said Riccardo Perfetti, MD, PhD, Chief Medical Officer at Applied Therapeutics.
  • “Diabetic Cardiomyopathy (DbCM) is a severe disease affecting approximately 20% of patients with diabetes.
  • The Phase 3 ARISE-HF study is investigating the potential benefit of AT-001 in treating DbCM, and we look forward to the data readout later this year.”

Applied Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Giovedì, Agosto 10, 2023
Insurance, ChromeOS, Sorbitol dehydrogenase, Chairperson, PIP, Journal, New Drug Application, European Medicines Agency, Diabetic cardiomyopathy, NDA, Quality of life, Medicine, Doctor of Philosophy, Brain cell, EMA, INSPIRE, US, Ongo, Galactitol, Phase 3, Patient, Investment, Treatment, Annual general meeting, Advanz Pharma, MAA, Research, FDA, Therapy, ADA, American Diabetes Association, US FDA, Safety, Disease, Pharmaceutical industry, Birth control, Galactosemia, EU, Sorbitol, SORD

NEW YORK, Aug. 10, 2023 (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 reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • “In the second quarter we continued to advance our programs across Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and Chair of the Board.
  • In June 2023, the Company presented baseline data at the 2023 Annual Meeting of the ADA from the ongoing Phase 3 ARISE-HF study of AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM).
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Net loss for the second quarter of 2023 was $29.6 million, or $0.37 per basic and diluted common share, compared to a net loss of $25.9 million, or $0.96 per basic and diluted common share, for the second quarter 2022.

Applied Therapeutics to Present Baseline Data on the Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association

Retrieved on: 
Giovedì, Giugno 22, 2023
Diabetes, Diabetic cardiomyopathy, Quality of life, N-terminal prohormone of brain natriuretic peptide, Face, Diagnosis, Therapy, American Diabetes Association

Baseline data from ARISE-HF shows a strong statistical correlation between elevations in the cardiac stress biomarker, NT-proBNP, reduced cardiac functional capacity and physical activity, underscoring the importance of early diagnosis via NT-proBNP and impact of DbCM on physical function and quality of life

Key Points: 
  • Baseline data from ARISE-HF shows a strong statistical correlation between elevations in the cardiac stress biomarker, NT-proBNP, reduced cardiac functional capacity and physical activity, underscoring the importance of early diagnosis via NT-proBNP and impact of DbCM on physical function and quality of life
    NEW YORK, June 22, 2023 (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 multiple presentations on AT-001 (caficrestat) and the ARISE-HF Phase 3 study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association to take place June 23 - 26 in San Diego, California.
  • Oral Symposium: Early Diagnosis of Diabetes Cardiomyopathy (DbCM)—What Can Be Done?
  • The Face of Diabetic Cardiomyopathy: Baseline Characteristics from the ARISE-HF Trial
    N-Terminal Pro-B Type Natriuretic Peptide Concentrations in Diabetic Cardiomyopathy: Baseline Data from the ARISE-HF Trial

Applied Therapeutics Reports First Quarter 2023 Financial Results

Retrieved on: 
Giovedì, Maggio 11, 2023
Cognition, Insurance, Partnership, Tremor, Galactose, Diabetic cardiomyopathy, NDA, Venrock, Doctor of Philosophy, Sale, Galactitol, Patient, Investment, MAA, Research, Therapy, Pharmaceutical industry, Cryptocurrency, Galactosemia, SORD

NEW YORK, May 11, 2023 (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 reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • NEW YORK, May 11, 2023 (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 reported financial results for the first quarter ended March 31, 2023.
  • “We are committed to bringing transformative therapies to patients with debilitating diseases and no treatment options, including Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.
  • In April 2023, the Company announced consistent long-term clinical benefit from the ACTION-Galactosemia Kids Phase 3 study of govorestat.
  • Net loss for the first quarter of 2023 was $10.1 million, or $0.18 per basic and diluted common share, compared to a net loss of $23.1 million, or $0.88 per basic and diluted common share, for the first quarter 2022.