U.S. markets open in 1 hour 40 minutes

ARCA biopharma, Inc. (ABIO)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
Add to watchlist
4.2600-0.0100 (-0.23%)
At close: 4:00PM EST
Full screen
Trade prices are not sourced from all markets
Gain actionable insight from technical analysis on financial instruments, to help optimize your trading strategies
Chart Events
Bullishpattern detected
Commodity Channel Index

Commodity Channel Index

Previous Close4.2700
Open4.2400
Bid4.2200 x 900
Ask4.3300 x 800
Day's Range4.2100 - 4.3500
52 Week Range2.2100 - 22.0000
Volume186,053
Avg. Volume657,800
Market Cap39.709M
Beta (5Y Monthly)2.86
PE Ratio (TTM)N/A
EPS (TTM)-2.1120
Earnings DateNov 02, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
Fair Value is the appropriate price for the shares of a company, based on its earnings and growth rate also interpreted as when P/E Ratio = Growth Rate. Estimated return represents the projected annual return you might expect after purchasing shares in the company and holding them over the default time horizon of 5 years, based on the EPS growth rate that we have projected.
Fair Value
XX.XX
Overvalued
Research that delivers an independent perspective, consistent methodology and actionable insight
Related Research
View more
  • MarketWatch

    ARCA Biopharma gets Fast Track designation for experimental COVID-19 treatment

    Shares of ARCA Biopharma Inc. gained 5.5% in trading on Monday after the company said it received a Fast-Track designation from the Food and Drug Administration for its mid-stage experimental COVID-19 treatment. ARCA plans to launch a Phase 2b clinical trial enrolling 100 hospitalized COVID-19 patients next month, and it anticipates that the first round of topline data from the study will be available in the second quarter of next year. ARCA's stock is down 31.9% so far this year, while the S&P 500 has gained 10.1%.

  • AB201 Development as a Potential Treatment for COVID-19 Receives U.S. FDA Fast Track Designation
    GlobeNewswire

    AB201 Development as a Potential Treatment for COVID-19 Receives U.S. FDA Fast Track Designation

    Dr. Bristow Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc. * 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 2021WESTMINSTER, Colo., Nov. 23, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19. The Company intends to initiate a Phase 2b clinical trial (ASPEN-COVID-19) of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020, with topline trial data anticipated in the second quarter of 2021.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.“Fast Track designation for the AB201 development program is an important acknowledgement of the critical need for treatments for hospitalized COVID-19 patients, whether effective vaccines are approved and available or not,” said Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. “We believe AB201’s combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19 and look forward to beginning the ASPEN-COVID-19 trial to evaluate AB201’s potential efficacy in this patient population."Fast Track drug development designation is included in the FDA Modernization Act of 1997 (FDAMA) as a formal process to enhance interactions with the FDA during drug development. A drug development program with Fast Track designation would be eligible for consideration for some or all of the following programs for expediting development and review: scheduled meetings to seek FDA input into development plans, priority review of the New Drug Application (NDA), the option of submitting portions of an NDA prior to submission of the complete application and potential accelerated approval. ARCA believes that AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation.About AB201 AB201 is a small recombinant protein being developed as a potential treatment for RNA virus-associated diseases, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives AB201 a combination of anticoagulant, anti-inflammatory and antiviral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways. AB201 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19 and other RNA virus associated diseases.About ARCA biopharma ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential pharmacogenetic treatment for atrial fibrillation in patients with heart failure. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for AB201, the expected features and characteristics of AB201, AB201’s potential to treat COVID-19, CAC or any other RNA virus associated disease, whether AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation and future treatment options for patients with COVID-19. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact: Derek Cole 720.940.2163 derek.cole@arcabio.comA photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740

  • ARCA biopharma Announces Third Quarter 2020 Financial Results  and Provides Corporate Update
    GlobeNewswire

    ARCA biopharma Announces Third Quarter 2020 Financial Results and Provides Corporate Update

    Dr. Bristow Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc. * Initiation of Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID19 anticipated in fourth quarter * Topline data from trial anticipated Q2 2021WESTMINSTER, Colo., Nov. 02, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported financial results for the third quarter of 2020 and provided a corporate update.Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “With the resurgence of SARS-CoV-2 across the country and around the globe, the need for effective therapies to treat patients hospitalized with COVID-19 remains an urgent priority. AB201’s combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. We are working rapidly towards initiating the Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID-19.”Pipeline UpdateAB201 (rNAPc2) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19. * Advancing development of AB201 as a potential treatment for patients hospitalized with COVID-19 * U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19 * ARCA estimates initiating Phase 2b clinical testing of AB201 in fourth quarter of this year Gencaro™ (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF). The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients. Initiation of the PRECISION-AF Phase 3 clinical trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. Future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.Third Quarter 2020 Summary Financial ResultsCash and cash equivalents were $51.1 million as of September 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022, including the projected costs for the AB201 Phase 2b clinical trial.Research and development (R&D) expense for the three months ended September 30, 2020 was $1.1 million compared to $0.3 million for the corresponding period of 2019, an increase of $0.7 million. R&D expense for the nine months ended September 30, 2020 was $1.8 million compared to $1.4 million for the corresponding period of 2019, an increase of approximately $0.3 million.Clinical expense increased approximately $0.3 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. Manufacturing process development costs increased approximately $0.2 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. The increase in costs were related to initial costs for the AB201 clinical trial, which the Company plans to initiate in the fourth quarter of 2020. The remaining increase is primarily a result of higher outside services and consulting costs.General and administrative (G&A) expenses were $0.9 million for both the three months ended September 30, 2020 and 2019. G&A expenses were $2.9 million and $3.1 million for the nine months ended September 30, 2020 and 2019, respectively. The $0.2 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020.Total operating expenses for the three months ended September 30, 2020 were $1.9 million compared to $1.2 million for the corresponding period in 2019. Total operating expenses for the nine months ended September 30, 2020 were $4.6 million compared to $4.5 million for the corresponding period in 2019.Net loss for the three months ended September 30, 2020 was $2.0 million, or $0.33 per basic and diluted share, compared to $1.2 million, or $0.76 per basic and diluted share, for the corresponding period in 2019.   Net loss for the nine months ended September 30, 2020 was $4.6 million, or $1.46 per basic and diluted share, compared to $4.3 million, or $3.46 per basic and diluted share, for the corresponding period in 2019.About ARCA biopharma ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, AB201’s potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, the potential for Gencaro to be the first genetically targeted AF prevention treatment and the ability of ARCA’s financial resources to support its operations through 2022. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact: Derek Cole 720.940.2163 derek.cole@arcabio.com(Tables follow) ARCA BIOPHARMA, INC.BALANCE SHEET DATA (in thousands) (unaudited) September 30, 2020  December 31, 2019  Cash and cash equivalents$51,095  $8,363  Working capital$50,409  $7,554  Total assets$51,982  $8,536  Total stockholders’ equity$50,455  $7,610           ARCA BIOPHARMA, INC. STATEMENTS OF OPERATIONS(unaudited) Three Months Ended  Nine Months Ended   September 30,  September 30,   2020  2019  2020  2019                             (in thousands, except share and per share amounts)  Costs and expenses:                Research and development$1,051  $347  $1,788  $1,449  General and administrative 939   900   2,852   3,087  Total costs and expenses 1,990   1,247   4,640   4,536  Loss from operations (1,990)  (1,247)  (4,640)  (4,536)                  Interest and other income 1   50   27   136  Interest expense (2)  (1)  (9)  (7) Loss before income taxes (1,991)  (1,198)  (4,622)  (4,407) Income tax benefit —   42   9   151  Net loss$(1,991) $(1,156) $(4,613) $(4,256)                  Net loss per share:                Basic and diluted$(0.33) $(0.76) $(1.46) $(3.46) Weighted average shares outstanding:                Basic and diluted 6,044,315   1,521,259   3,154,680   1,229,289                   A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740