|Bid||1.71 x 2200|
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|Day's Range||1.6500 - 1.9000|
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AzurRx BioPharma, Inc. (AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today provided a clinical development and strategic corporate update.
If you want to know who really controls AzurRx BioPharma, Inc. (NASDAQ:AZRX), then you'll have to look at the makeup of its share registry. Generally speaking, as a company grows, Read More...
AzurRx BioPharma, Inc. (AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has initiated the Company's Phase II OPTION study to investigate MS1819-SD in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The Phase II multi-center study is designed to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current porcine enzyme replacement therapy standard of care. Planned enrollment is expected to include approximately 30 CF patients, with study completion anticipated in 2019.
AzurRx BioPharma, Inc. (AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced that it is acquiring royalty and milestone obligations to its lead drug candidate MS1819-SD, a recombinant lipase for exocrine pancreatic insufficiency, from Protea Biosciences Group (“Protea”), who initiated Chapter 11 proceedings in December 2017. Following an auction held on November 27, 2018, AzurRx emerged as the successful bidder for contractual rights to milestone and royalty payments under a Stock Purchase and Sale Agreement previously executed by AzurRx and Protea.
Highlights for the period and to date include participation in investment conferences, presentation of favorable trial data, acceptance of a new IND and a nod of approval from the Therapeutics Development Network for their cystic fibrosis trial protocol. Financial results for the quarter reflect the interim between the chronic pancreatitis study and the cystic fibrosis study and show an expected dip in cash burn. Research and development expenses were up 21% compared to the prior year period as AzurRx established its R&D function in the United States and recognized related costs, but were down sequentially, representing a break between the CP and CF studies.
BROOKLYN, N.Y., Dec. 04, 2018 -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant.
Other endpoints were also positive, including Bristol stool scale, number of daily evacuations and weight of stool, which were consistent with the CFA results. CMO Dr. Pennington was pleased at the high level of statistical significance of the results and announced his expectation that the Phase IIb portion of the trial in cystic fibrosis (CF) will begin later in 2018. This compares to the dose response of just over 16% that was achieved in the Phase 1/2a FLIP110 study.
The company’s most important announcement year to date has been the completion of the Phase 2a trial for MS1819 in late June. Trial results were favorable and provided evidence of safety and efficacy for the Yarrowia lipolytica-derived lipase in exocrine pancreatic insufficiency (EPI). The company also raised $10 million in a public offering underwritten by Oppenheimer.
AzurRx BioPharma, Inc. (AZRX) announced the completion of the Phase IIa MS1819-SD trial on June 29, 2018 and expects to provide a formal report presenting the data in the fall of 2018 at an as yet unidentified scientific conference. As a reminder, the trial was a Phase 2a open-label, dose escalation study conducted in France, Australia and New Zealand with the goal of identifying the safety of escalating doses and dose response. It was conduted in conjuntion with Mayoly Spindler Laboratories and launched November 17, 2016.
AzurRx BioPharma, Inc. (AZRX) provided an update regarding its Phase 2a trial for MS1819 for treatment of chronic pancreatic insufficiency (EPI) The April 23rd release identified consistent progress in the Phase 2a trial for MS1819 with respect to patient enrollment, safety and dose response. The trial is targeting 12 – 15 patients and is enrolling in France, Australia and New Zealand. Current screening and enrollment trends are on track for a 1H:18 study completion.
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AzurRx BioPharma, Inc. (AZRX) filed their fiscal year 2017 10-K on March 16th providing a financial update on the company’s performance. The filing caps off a year that saw progression of the Phase IIa trial for MS 1819 for treatment of exocrine pancreatic insufficiency (EPI), new patent protection filings and new personnel and board additions. In 2018, the company received approval for a clinical site in France and continued to add new patients.
CLEARWATER, FL / ACCESSWIRE / March 2, 2018 / The AzurRx Biopharma, Inc. (NASDAQ: AZRX) research report is available on Stock Market Manager ( smm.global ): Research Report Here About AzurRx, Biopharma, ...