ARCA biopharma, Inc. - ABIO STOCK NEWS

ARCA biopharma (Nasdaq: ABIO) has published a paper analyzing bradycardia in heart failure patients with atrial fibrillation, highlighting the lower prevalence of clinically significant bradycardia with Gencaro compared to metoprolol. In a Phase 2B clinical trial, Gencaro showed a significantly reduced incidence of heart rates less than 50 beats/min at 0.24 episodes/patient vs. 0.57 for metoprolol (P < .0001). Additionally, 75% of Gencaro patients achieved target doses compared to 62% for metoprolol. The findings support the potential for Gencaro as a genetically targeted therapy in upcoming trials.

ARCA biopharma (ABIO) announced the completion of patient enrollment in the ASPEN-COVID-19 Phase 2b clinical trial, which evaluates rNAPc2 as a treatment for COVID-19 in hospitalized patients. A total of 160 patients were enrolled across the US, Argentina, and Brazil. The primary endpoint measures changes in D-dimer levels, a biomarker linked to coagulation issues common in COVID-19 patients. Topline results are expected in Q1 2022. The trial is part of a Fast Track program by the FDA, highlighting its potential significance as a treatment option.

ARCA biopharma (Nasdaq: ABIO) announced that COO Tom Keuer will present at the Q4 Virtual Investor Summit on November 17, 2021, at 4:15 PM ET. The presentation will be live-streamed and available for replay. ARCA focuses on genetically targeted therapies for cardiovascular diseases and has key projects in development, including rNAPc2, a potential COVID-19 treatment, and Gencaro™, a unique beta-blocker for atrial fibrillation in heart failure patients. Both projects have received Fast Track designation from the U.S. FDA.

ARCA biopharma (ABIO) reported Q3 2021 financial results, emphasizing significant advancements in their COVID-19 treatment trial, rNAPc2. An interim analysis recommended continuing the Phase 2b ASPEN-COVID-19 trial without modifications, with topline data expected in Q1 2022. Cash reserves stand at $58.3 million, sufficient to fund operations through 2022. R&D expenses increased to $3.4 million due to the rNAPc2 trial, while total operating expenses rose to $4.7 million. The net loss for the quarter was $4.7 million, equivalent to $0.33 per share.

ARCA biopharma (ABIO) announced positive progress in its ASPEN-COVID-19 Phase 2b clinical trial for rNAPc2, a potential treatment for severe COVID-19. The Data and Safety Monitoring Committee has completed an interim analysis, recommending trial continuation without changes. Enrollment of 160 patients is expected by year-end 2021, with topline results anticipated in Q1 2022. rNAPc2 is granted Fast Track designation by the FDA, and the trial aims to evaluate its efficacy against heparin in managing D-dimer levels, a critical biomarker in COVID-19 patients.

ARCA biopharma (Nasdaq: ABIO) has enrolled its first international patient in the Phase 2b clinical trial, ASPEN-COVID-19, focusing on rNAPc2 as a treatment for hospitalized COVID-19 patients. This trial, now approximately 75% enrolled, aims to evaluate rNAPc2's efficacy against heparin. Topline data is expected in Q4 2021. The FDA has granted Fast Track designation for rNAPc2, identifying it as a unique anticoagulant in development for COVID-19, which may address critical treatment needs.

ARCA biopharma (Nasdaq: ABIO) announced that CFO Jeff Dekker will present at the Q3 Virtual Investor Summit on August 18, 2021, at 1:15 PM ET. The company specializes in genetically targeted therapies for cardiovascular diseases and is developing rNAPc2 for RNA virus-related conditions, with a focus on COVID-19. The drug is in Phase 2b clinical testing and has received Fast Track designation from the FDA. Additionally, ARCA is developing Gencaro (bucindolol hydrochloride) as a treatment for atrial fibrillation in heart failure patients, also with Fast Track designation.

ARCA biopharma (Nasdaq: ABIO) has submitted a PCT patent application for its developmental drug rNAPc2 aimed at treating COVID-19 patients. This follows prior provisional applications and could secure market exclusivity for rNAPc2 until about 2040. The drug, which has shown efficacy in previous trials, acts as a tissue factor inhibitor, potentially addressing viral infections through anti-coagulant and anti-inflammatory mechanisms. The FDA has granted Fast Track designation for rNAPc2's development, now in Phase 2b clinical testing.

ARCA biopharma (ABIO) reported its Q2 2021 results, showing cash and cash equivalents of $63.2 million, sufficient to fund operations through 2022. The ongoing Phase 2b trial of rNAPc2 for COVID-19 is expanding to South America, with topline data expected in Q4 2021. R&D expenses surged to $3.6 million from $0.4 million YoY, while G&A expenses increased to $1.3 million. The net loss for Q2 2021 was $4.8 million, or $0.34 per share, compared to a loss of $1.3 million or $0.73 per share in Q2 2020.