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AzurRx BioPharma, Inc. (AZRX)

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Previous Close1.4800
Open1.4700
Bid0.0000 x 3200
Ask0.0000 x 3000
Day's Range1.4510 - 1.7296
52 Week Range0.3710 - 2.6300
Volume2,423,676
Avg. Volume7,909,283
Market Cap90.278M
Beta (5Y Monthly)1.69
PE Ratio (TTM)N/A
EPS (TTM)-0.8990
Earnings DateAug 13, 2019
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est4.50
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  • AzurRx BioPharma Appoints President and CEO James Sapirstein as New Chairman of the Board of Directors
    GlobeNewswire

    AzurRx BioPharma Appoints President and CEO James Sapirstein as New Chairman of the Board of Directors

    Former Chairman Edward J. Borkowski to continue as the lead independent director on the boardDELRAY BEACH, Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the appointment of James Sapirstein, President and CEO, as chairman of the company’s board of directors, effective immediately. Mr. Sapirstein succeeds Mr. Edward J. Borkowski, who joined the AzurRx board in May 2015 and has served as chairman since April 2016. Mr. Borkowski will remain as lead independent director of the board of directors. “AzurRx is on the verge of several important inflection points, and I am pleased to take on additional responsibilities at this exciting stage in the company's evolution,” said Mr. Sapirstein. “I look forward to working with Ed and the other Board members to propel a business and clinical strategy that, I believe, has the potential to transform AzurRx and generate substantial value for the company and our shareholders. I look forward to advancing the clinical programs for our lead investigational candidate, MS1819, and our novel niclosamide therapies to rapidly deliver safe and efficacious product candidates to patients who need them the most.” Mr. Sapirstein added, “On behalf of the Board, I want to express my appreciation to Ed for his years of service to AzurRx. Under his dedicated stewardship, AzurRx has advanced its mission to develop world-class medicines that address serious disease-related GI complications. I am grateful for all that Ed has contributed to AzurRx and look forward to his ongoing input as a member of the Board and our lead independent director.” “Having served on AzurRx’s Board since 2015, I am committed to ensuring a prosperous future for the company,” stated Mr. Borkowski. “Under James’ leadership, AzurRx has strategically expanded its existing pipeline to pursue new opportunities in the treatment of gastrointestinal conditions. The recent licensing agreement with First Wave Bio represents an exciting new chapter in the company’s growth with the potential to generate both near-term and long-range returns for AzurRx shareholders. James has been instrumental in implementing this strategy, and he is ideally suited to lead the company as both Chairman and CEO as we seek to maximize the full potential of AzurRx’s pipeline and advance our clinical development programs.” About James Sapirstein James Sapirstein was named President and Chief Executive Officer of AzurRx Therapeutics in October 2019 Mr. Sapirstein arrived at AzurRx from ContraVir Pharmaceuticals, Inc. (now known as Hepion Pharmaceuticals, Inc.), where he served as chief executive officer and board member. His career in the pharmaceutical industry has spanned nearly 37 years with extensive expertise in drug development and commercialization. Mr. Sapirstein has participated in 23 product launches, including six global launches that he led, and headed numerous business development transactions. Prior to ContraVir, Mr. Sapirstein served as CEO of Alliqua Therapeutics, as the founding CEO of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology for Serono Laboratories. Mr. Sapirstein has also held senior level positions at Gilead, Bristol Myers Squibb and Hoffmann-LaRoche. Mr. Sapirstein currently sits on the boards of Marizyme, Leading Biosciences and Enochian Biosciences. He also sits on the board on the Biotechnology Innovation Organization’s (BIO) Emerging Companies Board and serves as Chairman Emeritus of BioNJ. Mr. Sapirstein earned a B.S. in Pharmacy from Rutgers University and received an MBA in Management from Fairleigh Dickinson University. About AzurRx BioPharma, Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com. Forward-Looking StatementThis press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: AzurRx BioPharma, Inc.1615 South Congress AvenueSuite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Media contact: Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com Investor Relations contact: LifeSci Advisors, LLC. Hans Vitzthum, Managing Director 1 International Place, Suite 1480 Boston, MA 02110 Phone: (617) 430-7578 hans@lifesciadvisors.com

  • AzurRx BioPharma to Present at The Microcap Rodeo Winter Wonderland Conference
    GlobeNewswire

    AzurRx BioPharma to Present at The Microcap Rodeo Winter Wonderland Conference

    DELRAY BEACH, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer, will present at The Microcap Rodeo Winter Wonderland Conference taking place virtually from February 16-19, 2021. During his live virtual presentation on February 17th at 4:30 p.m., Eastern Time, Mr. Sapirstein will provide an overview of AzurRx’s business and clinical development programs and discuss anticipated 2021 milestones. Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one meetings with registered investors. Details of the presentation are as follows: Event: The Microcap Rodeo Winter Wonderland ConferenceDate: February 17, 2021Time: 4:30 p.m. Eastern TimeRegistration: https://microcaprodeo.com/signupPresentation: https://www.webcaster4.com/Webcast/Page/2134/40075 About AzurRx BioPharma, Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI clinical programs. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida. with clinical operations in Hayward, California. For more information visit www.azurrx.com. Forward-Looking StatementsThis press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: AzurRx BioPharma, Inc.1615 South Congress AvenueSuite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Investor Relations contact: LifeSci Advisors, LLC. Hans Vitzthum, Managing Director 1 International Place, Suite 1480 Boston, MA 02110 Phone: (617) 430-7578 hans@lifesciadvisors.com Media contact: Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com

  • AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections
    GlobeNewswire

    AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections

    Phase 2 Study of oral niclosamide planned for 1H 2021 DELRAY BEACH, Fla., Feb. 09, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has entered into an agreement with PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO), for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal (GI) infections. Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022. Licensed by AzurRx in January from FirstWave Bio, Inc., the goal of AzurRx’s FW-1022 clinical program is to develop a safe, effective, non-systemic treatment for GI infections related to COVID-19. AzurRx anticipates initiating the trial in the first half of 2021. “We are moving rapidly to initiate the planned Phase 2 trial of FW-1022 and are pleased to have PPD as our CRO partner given the company’s proven expertise and track record of clinical excellence,” said James Sapirstein, President and CEO of AzurRx BioPharma. “Even as the vaccine rollout continues, millions of people will become infected with the SARS-CoV-2 virus, and recent study data suggest approximately 1 in 5 of those stricken will suffer COVID-related GI infections with symptoms that include loss of appetite, nausea, vomiting and diarrhea. There is no therapeutic available to treat this condition, and we believe FW-1022 offers the potential to address this serious and possibly long-lasting after-effect of COVID-19.” Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, stated, “PPD is pleased to support AzurRx’s efforts to bring relief to patients suffering from COVID-19-related GI infections. We recognize the breakthrough nature of AzurRx’s work with FW-1022 and look forward to applying our capabilities and expertise to the development of FW-1022, beginning with the planned Phase 2 clinical trial.” About COVID-19 Gastrointestinal InfectionsGastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases1. Of the 26.6 million individuals who are reported to have contracted COVID-19 in the U.S., this would translate into 4.8 million patients having GI infection. Of the 105 million cases globally, it would translate into almost 19 million patients. There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections. About NiclosamideNiclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties. There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.2 Additionally, emerging evidence confirms the severe GI-related complications of COVID and potential fecal spread of the virus. The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly. FW-1022FW-1022 is a niclosamide based small molecule which the Company’s clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 will be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-1022 has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread. About AzurRx BioPharma, Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com. About PPD PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppd.com. Forward-Looking StatementThis press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: AzurRx BioPharma, Inc.1615 South Congress AvenueSuite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Media contact: Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com Investor Relations contact: LifeSci Advisors, LLC. Hans Vitzthum, Managing Director 1 International Place, Suite 1480 Boston, MA 02110 Phone: (617) 430-7578 hans@lifesciadvisors.com 1 Gut Journal: Vol 69, Issue 6: 2020; Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 20202 Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.