arca biopharma inc (ABIO) Key Developments
ARCA biopharma, Inc. Proposes Amendments to the Restated Certificate of Incorporation
Apr 14 15
ARCA biopharma, Inc. proposed to approve amendments to the Company’s restated certificate of incorporation, as amended, and authorize the Board of Directors, if in their judgment it is necessary, to select and file one such amendment to effect a reverse stock split of common stock, at a ratio in the range of 3:1 to 20:1, such ratio to be determined at the discretion of the Board of Directors, to it's annual general meeting to be held on June 04, 2015.
ARCA biopharma, Inc. Announces Investigation of Gencaro for the Prevention of Atrial Fibrillation/Atrial Flutter by U.S. Food and Drug Administration (FDA)
Apr 13 15
ARCA biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Gencaro for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction, HFREF). Gencaro is the company's investigational, pharmacologically unique beta-blocker and mild vasodilator. According to the FDA's Fast Track Guidance document, Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Gencaro is currently being evaluated as a potential treatment for atrial fibrillation in a genetically-defined heart failure (HFREF) population in GENETIC-AF, a Phase 2B/3 adaptive design clinical trial. ARCA anticipates that enrollment of approximately 200 patients in the Phase 2B portion of the trial will be completed by the end of 2016.
ARCA biopharma, Inc. Auditor Raises 'Going Concern' Doubt
Mar 19 15
ARCA biopharma, Inc. filed its 10-K on Mar 19, 2015 for the period ending Dec 31, 2014. In this report its auditor, KPMG LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.
ARCA biopharma, Inc. Provides GENETIC-AF Clinical Trial Update
Mar 16 15
ARCA biopharma, Inc. provided an update on GENETIC-AF, the Company's Phase 2B/3 clinical trial evaluating Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF). GENETIC-AF is a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of AF in patients with heart failure and left ventricular systolic dysfunction (HFREF patients). The primary endpoint of GENETIC-AF is time to symptomatic AF/atrial flutter (AFL). ARCA is enrolling only HFREF patients with the genetic variant of the cardiac beta-1 adrenergic receptor, which the company believes responds most favorably to Gencaro, the 389 arginine homozygous genotype (ADRB1 Arg389Arg). GENETIC-AF has an adaptive design, under which the company initiated the trial as a Phase 2B trial seeking to enroll approximately 200 patients. The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain data from the Phase 2B portion of the trial and recommend, based on a comparison to the pre-trial statistical assumptions, whether the trial should proceed to Phase 3 and seek to enroll an additional 420 patients. There are currently 38 active clinical trial sites in the United States and Canada. The company anticipates that approximately 65 sites will be activated for the Phase 2B portion of GENETIC-AF. Trial enrollment, the number of patients randomized into one of the study's two treatment arms, has not met the company's original projections, with the trial having screened 37 patients who met the general clinical inclusion criteria and signed informed consent for genotyping, resulting in 12 patients who were randomized into the trial. The percentage of screened patients who have the targeted genotype is consistent with pre-trial assumptions of approximately 50%.
ARCA biopharma Receives Non-Compliance Notice From NASDAQ
Feb 23 15
On February 18, 2015, ARCA biopharma, Inc. received a notice from The Nasdaq Stock Market (NASDAQ) indicating that ARCA’s common stock (the “Common Stock”) does not meet the continued listing requirement as set forth in NASDAQ Rule 5550(a)(2) based on the closing bid price of the Common Stock for the preceding 30 business days. The minimum closing bid price required to maintain continued listing on The Nasdaq Capital Market is $1.00 per share. Under NASDAQ Rule 5810(c)(3)(A), ARCA has a 180 calendar day grace period from the date of the Notice to regain compliance by meeting the continued listing standard. The continued listing standard will be met if the Common Stock has a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar day grace period. If ARCA does not regain compliance within the 180 calendar day grace period, it will be afforded an additional 180 calendar day compliance period, provided that on the 180th day of the first grace period ARCA (i) meets the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the bid price requirement) based on ARCA’s most recent public filings and market information and (ii) notifies NASDAQ of its intent to cure this deficiency. If ARCA does not indicate its intent to cure the deficiency or if it does not appear to NASDAQ that it would be possible for ARCA to cure the deficiency, ARCA would not be eligible for the second 180 day compliance period, and its securities would then be subject to delisting from the Nasdaq Capital Market. If ARCA is unable to regain compliance during the first 180 calendar day grace period or, if applicable, the second 180 day compliance period, and receives a delisting determination from NASDAQ it may, at that time, request a hearing to remain on The Nasdaq Capital Market, which request will ordinarily suspend such delisting determination until a decision by NASDAQ subsequent to the hearing. There can be no assurance that ARCA will be successful in maintaining its listing of the Common Stock on The Nasdaq Capital Market. This could impair the liquidity and market price of the Common Stock. In addition, the delisting of the Common Stock from a national exchange could materially adversely affect the ARCA’s access to capital markets, and any limitation on market liquidity or reduction in the price of the Common Stock as a result of that delisting could adversely affect ARCA’s ability to raise capital on terms acceptable to ARCA, or at all.