American College

EQS-News: Abivax reports 2023 financial results and operational update

Retrieved on: 
Wednesday, April 10, 2024
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Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Retrieved on: 
Tuesday, April 2, 2024
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"Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Key Points: 
  • "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.
  • In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  • In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study.
  • In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline.

iCAD’s ProFound AI Suite Uncovers Hidden Heart Disease Risk According to New Data Presented at American College of Cardiology Meeting

Retrieved on: 
Monday, April 8, 2024
Prevalence, Cardiovascular disease, Sudden death, Radiology, Blood, Risk, Physician, ICAD, Patient, Ageing, Stroke, Research, Breast, Angiography, Death, Woman, American College, Breast cancer, Literature, Prognosis, Moyamoya disease, ACC, Medical imaging

The 15-site prospective study included 2D screening mammograms from women ages 20 to 100, with a median age of 56.

Key Points: 
  • The 15-site prospective study included 2D screening mammograms from women ages 20 to 100, with a median age of 56.
  • “The ProFound BAC AI algorithm may provide a critical surrogate biomarker for women at risk of heart disease or stroke,” said Dana Brown, president and CEO of iCAD.
  • The study also suggests the ProFound Heart Health AI algorithm can standardize BAC detection, potentially improving efficiency and reducing variability among observers.
  • Early cardiovascular disease detection is key, as among asymptomatic women, the first manifestation of underlying coronary heart disease is often acute myocardial infarction (MI) or sudden death.

Shockwave Reducer Demonstrates Consistent, Positive Results in ‘Real-World’ Study

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Monday, April 8, 2024
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These findings confirm the positive, ‘real-world’ outcomes of Shockwave Reducer, a novel technology for the treatment of refractory angina.

Key Points: 
  • These findings confirm the positive, ‘real-world’ outcomes of Shockwave Reducer, a novel technology for the treatment of refractory angina.
  • Results were presented earlier today at the 73rd Annual Scientific Sessions of the American College of Cardiology in Atlanta, GA.
    REDUCER-I is a post-market, multi-center, observational study designed to collect long-term outcomes on Shockwave Reducer in a large, ‘real-world’ population of 400 patients.
  • “Results from the REDUCER-I study continue to demonstrate the safety and effectiveness of Shockwave Coronary Sinus Reducer as a novel therapy for refractory angina,” said Dr. Verheye.
  • Results from COSIRA-II are intended to support the regulatory filing for US FDA approval of Shockwave Reducer.

Positive Results for Patients with Non-obstructive Hypertrophic Cardiomyopathy Treated with Ninerafaxstat in the Phase 2 IMPROVE-HCM Trial Presented During a Late-Breaking Clinical Trial Session at ACC.24

Retrieved on: 
Monday, April 8, 2024
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BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to improve patient symptoms and functional capacity by enhancing cellular energetics, today announced that results from the Phase 2 IMPROVE-HCM clinical trial, evaluating ninerafaxstat in patients with symptomatic nHCM, were presented in a late-breaking clinical trial session at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24) and published in the Journal of the American College of Cardiology (JACC).

Key Points: 
  • “We are pleased with the IMPROVE-HCM clinical trial results presented today at ACC and simultaneously published in JACC, confirming the importance of these results for patients living with nHCM,” said Anne Prener, M.D., Ph.D., president and chief executive officer of Imbria Pharmaceuticals.
  • “Based on these positive results, we plan to initiate the Phase 3 FORTITUDE-HCM clinical trial in patients with symptomatic nHCM later this year.
  • Most treatment emergent adverse events (AEs) were self-limiting and mild to moderate in severity occurring in 24 ninerafaxstat treated patients (70.6%) vs. 20 patients on placebo (60.6%).
  • improved) from 31.2 to 30.9 in the ninerafaxstat treated group and worsened from 32.7 to 34.3 in the placebo group.

Milestone® Pharmaceuticals Announces Etripamil Data Demonstrating Patients’ Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting

Retrieved on: 
Monday, April 8, 2024
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“The promising results of this real-world design study demonstrated patients’ ability to self-manage multiple episodes of PSVT with etripamil,” said David Bharucha, MD, PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals.

Key Points: 
  • “The promising results of this real-world design study demonstrated patients’ ability to self-manage multiple episodes of PSVT with etripamil,” said David Bharucha, MD, PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals.
  • CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, if approved, will be the first rapid, reliable, and at-the-ready option in the acute treatment of PSVT.
  • NODE-303 (ClinicalTrials.gov ID NCT04072835 ) evaluated self-administered etripamil (70 mg, nasal spray) in an outpatient setting for up to multiple episodes of PSVT, without prior test dosing.
  • Both the presentation and publication will be available on the Milestone Pharmaceuticals corporate website at the conclusion of the ACC presentation.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
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ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

Retrieved on: 
Saturday, April 6, 2024
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DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted two data presentations at ACC.24 describing the effects of VASCEPA®/VAZKEPA® (icosapent ethyl) on reducing MACE (Major Adverse Cardiovascular Events) in patients with baseline high or low Lipoprotein(a) [Lp(a)] levels, as well as reducing the risk of cardiovascular (CV) events in patients irrespective of baseline LDL-C level. The REDUCE-IT analysis results relating Lp(a) concentrations with CV risk were also published online today in the Journal of the American College of Cardiology (JACC).

Key Points: 
  • There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high Lp(a) levels.
  • In this subanalysis, there were 7,026 REDUCE-IT patients with baseline Lp(a) data and a median Lp(a) value of 11.6 (Q1-Q3: 5.0-37.4) mg/dL.
  • Importantly, the treatment benefit of IPE was evident across subgroups with both high (≥50 mg/dL) and low (
  • Limitations are that randomization was not stratified by baseline LDL-C, however, baseline characteristics were similar among the two baseline LDL-C subgroups.

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

Retrieved on: 
Thursday, April 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)

PETVIVO HOLDINGS, INC. TO EXHIBIT AT THE ACVSMR SYMPOSIUM IN NAPLES FLORIDA

Retrieved on: 
Wednesday, April 3, 2024
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PetVivo intends to exhibit its lead product, SPRYNG™ with OsteoCushion™ Technology.

Key Points: 
  • PetVivo intends to exhibit its lead product, SPRYNG™ with OsteoCushion™ Technology.
  • Spryng is an intra-articular injectable veterinary medical device composed of sterilized, extra-cellular matrix microparticles.
  • The microparticles of Spryng have been found to adsorb onto the joint synovial lining of animals and subsequently integrate with the animal’s subsynovial tissue.
  • Such action promotes the restoration of proper joint mechanics, thereby aiding in the management of noninfectious sources of joint pain such as joint instability, degenerative joint disease and osteoarthritis.