ARCA biopharma, Inc. (NASDAQ:ABIO) Files An 8-K Other Events

ARCA biopharma, Inc. (NASDAQ:ABIO) Files An 8-K Other Events
Item 8.01.

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On November 23, 2020, ARCA biopharma, Inc., or the Company, announced that the U.S. Food and Drug Administration, has designated as a Fast Track development program the investigation of AB201 for the treatment of COVID-19. The Company anticipates initiating the Phase 2b clinical trial of AB201 in December 2020, with topline data anticipated in the second quarter of 2021. The press release related to these items is filed as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.

Section 9 — Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

ARCA biopharma, Inc. Exhibit
EX-99.1 2 abio-ex991_6.htm EX-99.1 abio-ex991_6.htm   Exhibit 99.1         AB201 Development as a Potential Treatment for COVID‑19 Receives U.S. FDA Fast Track Designation   – Development addresses need for treatments for patients hospitalized with COVID-19 whether vaccines are available or not   – AB201 is the only novel compound being developed for COVID Associated Coagulopathy   – Initiation of ASPEN-COVID-19 Phase 2b clinical trial anticipated in December   – Topline trial data anticipated Q2 2021 Westminster,…
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About ARCA biopharma, Inc. (NASDAQ:ABIO)

ARCA biopharma, Inc. (ARCA) is a biopharmaceutical company. The Company is principally focused on developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate is Gencaro (bucindolol hydrochloride), a beta-blocker and mild vasodilator that the Company is evaluating in a clinical trial for the treatment of atrial fibrillation (AF) in patients with heart failure with reduced left ventricular ejection fraction (HFREF). Gencaro is considered part of the beta-blocker class of compounds because of its property of blocking both beta-1 and beta-2, receptors in the heart. The blocking of these receptors prevents the receptor from binding with other molecules, primarily the neurotransmitter norepinephrine (NE), which activate these receptors. The Company is conducting a Phase IIB/III clinical trial of Gencaro, known as GENETIC-AF.

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