NYHA

Cytokinetics Reports First Quarter 2024 Financial Results

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onsdag, maj 8, 2024
FDA, Investment, Research, CHMP, Webcast, Business, Navigation, Metoprolol, Library classification, Journal, European Medicines Agency, Heart failure, Corporation, Congress, Obstruction, Food, Activate, Conference, Mended Hearts, Corporate social responsibility, ALS, Committee, Cardiovascular disease, Telephone, Safety, Assessment, Cytokinetics, NYHA, EMA, Biology, Clinical trial, Ethics, Organization, Woman, American College, NDA, MAA, Cohort, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2024. Net loss for the first quarter was $135.6 million, or $1.33 per share, compared to net loss for the first quarter of 2023 of $131.3 million, or $1.38 per share. Cash, cash equivalents and investments totaled $634.3 million at March 31, 2024.

Key Points: 
  • Announced Topline Data from the Phase 1 Study of CK-586;
    SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2024.
  • Announced the appointment of Sung Lee to serve as the Company’s Executive Vice President, Chief Financial Officer effective as of May 8, 2024.
  • Revenues for the first quarter 2024 were $0.8 million compared to $4.6 million for the corresponding period in 2023.
  • Members of Cytokinetics’ senior management team will review the company’s first quarter 2024 results on a conference call today at 4:30 PM Eastern Time.

Cytokinetics Announces Start of CEDAR-HCM, a Clinical Trial of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy

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onsdag, maj 8, 2024
DSM-IV codes, Patient, Adolescence, Safety, Obstruction, LVEF, Risk, Pharmacokinetics, Cytokinetics, NYHA, Research and development, Arrhythmia, Mercury (element), Library classification, Heart failure, Clinical trial, Quality of life, SAN, Ageing

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment.
  • Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM.
  • HCM can present similarly in adolescents and children as it does in adults and may negatively impact overall quality of life.
  • Patients will be randomized on a 2:1 basis to receive aficamten or placebo, and those receiving aficamten will begin with 5 mg dosed once daily.

Affluent Medical : 2023 financial results and update on clinical activities under development.

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fredag, maj 3, 2024
Medtech, FDA, Risk, De novo, Death, Mitral regurgitation, Doctor of Philosophy, Wound healing, Mitral valve annuloplasty, Boston Scientific, Ticker, Wealth, Urinary incontinence, Woman, Christophe, Food, Neurostimulation, Myocardial infarction, Aix-en-Provence, DSM-IV codes, LCEA, Mitral valve, TAVI, Minerva, Certification, Heart, Quality assurance, System, Anatomy, Exercise, NYHA, Dry, Marketing, Clinical trial, American College, Development director, MD, Endocarditis, Medtronic, Patient, Tricuspid valve, Acquisition, Medical device

Affluent Medical : 2023 financial results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2023 financial results and update on clinical activities under development.
  • Affluent Medical estimates that KaliosTM would avoid repeat surgery for 30-40% of patients within five years of their operation.
  • In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after one year of implantation.
  • In July 2023, Affluent Medical announced the appointments of Christophe de Vregille as Chief Financial Officer and Benjamin Renault as Development Director.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

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onsdag, april 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

CVRx announces availability of additional data supporting long-term benefits of Barostim

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måndag, april 15, 2024
Pain, FDA, Patient, CCM, GDMT, Risk, Abstract, Vanderbilt University, Death, THT, Depression, Heart failure, NYHA, Science, European Journal, Fatigue, CRT, Manuscript, Hospital, LVAD, Quality of life, Therapy, HF, Hykes, Pharmaceutical industry

MINNEAPOLIS, Minn., April 15, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.

Key Points: 
  • (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure.
  • These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.
  • CVRx previously announced some of these data as part of expanded labeling granted by FDA on December 23, 2023.
  • We look forward to the generation of additional evidence about Barostim from the BeAT-HF trial, as well as from real-world experience through our REBALANCE post-market registry and investigator-initiated research,” said Hykes.

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Retrieved on: 
onsdag, april 3, 2024
Cardiorenal syndrome, Congestion, DSR, Brussels Stock Exchange, Liver disease, Associate, RED, Patient, NYHA, Mortality, Cancer, Fluid, Heart failure, European Journal, Diuretic, Overload, Syndrome, Yale University, Pharmaceutical industry

The publication can be accessed here .

Key Points: 
  • The publication can be accessed here .
  • Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
  • Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
  • Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

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onsdag, mars 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

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tisdag, mars 19, 2024
CSL Vifor, University, Research, Exercise, Classification, Health professional, Risk, Patient, Public, Palpitations, Health care, NYHA, News, Periodic breathing, Cardiovascular Research, Quality of life, Health Canada, Woman, Heart failure, Anemia, Fatigue, Hospital, Dietary supplement

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.

Key Points: 
  • Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.
  • "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency."
  • Iron deficiency affects one in every two hospitalized patients with heart failure5.
  • * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms.

First Patient Randomized in AskBio Phase II Gene Therapy Trial for Congestive Heart Failure

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fredag, februari 16, 2024
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Heart, Gene, NYHA, Doctor of Philosophy, News, Ageing, Cardiomyopathy, CHF, Executive Committee, Heart failure, Safety, Bayer, Patient, Guideline, Disease, Phase, Committee, Pharmaceutical industry

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).

Key Points: 
  • Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
  • “GenePHIT will evaluate the safety and efficacy of AB-1002 in the largest number of patients to date and improve our understanding of gene therapy overall for the treatment of congestive heart failure.
  • “The enrollment of this first patient in the Phase II trial represents the culmination of many years of dedicated research and development in all aspects of cardiac gene therapy for congestive heart failure.
  • AB-1002 is manufactured by Viralgen Vector Core, S.L., a wholly owned and independently operated subsidiary of AskBio.

Impulse Dynamics Completes $136M Financing Round

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onsdag, februari 14, 2024
CCM, NYHA, Investment, Quality of life, Trial of the century, AIM, Feedback, Heart failure, Safety, Attention, ICD, CRT, Patient, Guideline, Clinical trial, HF, Heart, EF

The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare.

Key Points: 
  • The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare.
  • This substantial investment reflects investor confidence in, and commitment to, the company’s vision and expansion.
  • “This round of funding will accelerate our business, both commercially and with our pipeline of advanced technology innovation,” said Jason Spees, CEO of Impulse Dynamics.
  • “We are thrilled by the ongoing support from top-tier investment groups for Impulse Dynamics,” said Shlomi Nachman, Chairman of the Board.