Welcome to our dedicated page for ARCA biopharma news (Ticker: ABIO), a resource for investors and traders seeking the latest updates and insights on ARCA biopharma stock.
ARCA biopharma, Inc. (Nasdaq: ABIO) is a clinical-stage biopharmaceutical company that employs a precision medicine approach to develop and commercialize targeted therapies for cardiovascular diseases. Founded on the principle that individualized genetic profiles can enhance treatment efficacy, ARCA's lead development program focuses on Gencaro™ (bucindolol hydrochloride), aimed at treating atrial fibrillation (AF) in patients with chronic heart failure (HF). By leveraging genetic insights to predict patient responses, Gencaro™ aspires to be the first genetically-targeted prevention treatment for AF.
In addition to Gencaro™, ARCA is advancing rNAPc2 as a potential treatment for COVID-19 and possibly other viral diseases. rNAPc2 targets COVID-19 patients exhibiting coagulopathy biomarkers, and clinical trials have shown its benefit in reducing D-dimer levels, albeit without achieving statistical significance in primary efficacy endpoints. The company continues to explore strategic options for the development of its assets, including partnerships and other avenues.
Recent achievements include ARCA's ongoing strategic review to maximize stockholder value and its retention of Ladenburg Thalmann & Co. Inc. as a financial advisor. The company reported significant cash reserves sufficient to fund operations through 2024, reflecting prudent financial management despite the challenges posed by the ongoing development of its clinical programs.
ARCA is also evaluating the impact of recent clinical trial data and restructuring efforts aimed at optimizing operational costs. With its commitment to precision medicine, ARCA biopharma remains dedicated to improving the treatment landscape for cardiovascular diseases through innovative, genetically-targeted therapies.
ARCA biopharma (ABIO) announced positive findings from the GENETIC-AF trial of Gencaro (bucindolol) in heart failure patients, showing significant advantages over metoprolol. The analysis revealed a 36% reduction in cumulative atrial fibrillation (AF) burden and a 55% reduction in daily AF burden. Additionally, Gencaro led to a 32% reduction in rhythm control interventions and a 39% increase in normal sinus rhythm. A new patent for Gencaro was issued for treating AF in patients with ejection fractions over 40%, addressing a market need with few approved therapies.
ARCA biopharma announced an update on its Phase 2b clinical trial, ASPEN-COVID-19, aimed at evaluating rNAPc2 for treating hospitalized COVID-19 patients. The trial, now expanded to South America with regulatory approvals in Argentina and Brazil, has increased its target enrollment from 100 to 160 patients to enhance data reliability. As of now, 77 patients have been enrolled, with topline results expected in Q4 2021. rNAPc2 is viewed as a promising therapy due to its potential anti-coagulant and anti-inflammatory properties, particularly crucial amidst the ongoing pandemic.
ARCA biopharma (Nasdaq: ABIO) announced the participation of COO Thomas Keuer at the Access to Giving Virtual Investor Conference from July 13-15, 2021. The company will present on July 13 at 2:00 PM ET, focusing on precision medicine for cardiovascular diseases. ARCA is developing rNAPc2 for RNA virus-related diseases and Gencaro for atrial fibrillation, both of which have received Fast Track designations from the FDA. The conference aims to promote investor education and advocacy.
ARCA biopharma (Nasdaq: ABIO) has secured exclusive world-wide patent rights for rNAPc2, a potential COVID-19 treatment, in collaboration with the University Medical Center Mainz. This recombinant protein therapeutic is currently undergoing a Phase 2b clinical trial (ASPEN-COVID-19) and has received Fast Track designation from the FDA. The agreement may lead to €1.6 million in obligations and royalties upon commercialization. ARCA’s management believes rNAPc2 could effectively combat COVID-19 and other viral infections, leveraging its anticoagulant and anti-inflammatory properties.
ARCA biopharma (Nasdaq: ABIO) reported its Q1 2021 financial results, highlighting ongoing advancements in its Phase 2b clinical trial for rNAPc2 as a COVID-19 treatment, with topline data expected by Q3 2021. As of March 31, 2021, the company had cash and cash equivalents of $66.9 million, anticipated to fund operations through 2022. R&D expenses increased to $2.9 million due to trial initiation, while total operating expenses rose to $4.1 million, leading to a net loss of $4.1 million, or $0.33 per share.
ARCA biopharma (Nasdaq: ABIO) announced the appointment of Christopher Graybill, Ph.D., as Vice President of Clinical Development. Dr. Graybill brings over 14 years of experience in biotechnology and medical device industries, essential for advancing the development of key therapies such as rNAPc2 and Gencaro. The FDA has granted Fast Track designation to both therapies, with rNAPc2 currently in Phase 2 clinical testing for COVID-19 and Gencaro aiming to prevent atrial fibrillation in heart failure patients, utilizing genetic variations for tailored treatment.
ARCA biopharma (Nasdaq: ABIO) has appointed C. Jeff Dekker as its new Chief Financial Officer, effective May 10, 2021. Dekker brings over 25 years of biotech and finance experience, previously serving in various roles at GlobeImmune. The announcement follows Brian Selby's departure after 14 years. CEO Dr. Michael Bristow expressed confidence in Dekker's capabilities to drive clinical development and corporate strategies. ARCA is focused on genetically targeted therapies for cardiovascular diseases and is actively developing rNAPc2 for COVID-19 and Gencaro for atrial fibrillation.
ARCA biopharma (ABIO) reported its 2020 financial results and provided updates on its pipeline. The company is actively enrolling patients in a Phase 2b trial for rNAPc2, targeting COVID-19 treatment, with topline data expected in Q3 2021. A new patent for Gencaro, aimed at treating atrial fibrillation in heart failure patients, has been issued, extending coverage to 2039. As of December 31, 2020, cash and cash equivalents were $49.1 million. However, the net loss for 2020 was $9.7 million, or $2.07 per share, a significant increase from the previous year's loss.
ARCA biopharma (ABIO) has initiated the ASPEN-COVID-19 Phase 2b clinical trial for rNAPc2, targeting treatment for hospitalized COVID-19 patients. The trial aims to evaluate rNAPc2's efficacy against COVID-19 Associated Coagulopathy, marking it as a unique therapy option. The first patient was enrolled on December 10, 2020, with topline data expected in Q2 2021. The FDA has fast-tracked the development of rNAPc2, recognizing its potential as a novel anticoagulant with anti-inflammatory and antiviral properties.
ARCA biopharma (Nasdaq: ABIO) announced a change in the location of its 2020 Annual Meeting of Stockholders to its Westminster, CO offices due to COVID-19 restrictions. Scheduled for December 10, 2020, the meeting will follow health guidelines with limited seating and mandatory face coverings. Attendees unable to join in person will have remote participation options. For further details, the company's Notice of 2020 Annual Meeting and Proxy Statement is available on their website. ARCA is focused on developing therapies for cardiovascular diseases and RNA virus-related conditions, including COVID-19.
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