|Bid||0.8300 x 1000|
|Ask||0.8499 x 3000|
|Day's Range||0.8292 - 0.8700|
|52 Week Range||0.3710 - 1.9380|
|Beta (5Y Monthly)||2.04|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Under the terms of the agreement, Creapharm will package, label, provide qualified person (QP) release and distribute AzurRx’s MS1819 clinical trial drug product for both the upcoming Phase 2b OPTION 2 Monotherapy and the ongoing Phase 2 Combination Therapy clinical trials for the treatment of EPI in patients with Cystic Fibrosis (CF). MS1819 clinical trial drug supply will be sent directly to clinical sites in the U.S. and in Europe, including, Poland, Hungary, Spain and Turkey from Creapharm’s U.S. and European depots, respectively.
This marks the third CIR payment AzurRx SAS has received in 2020. Since March including the 2019 CIR, the Company has received approximately $2.52 million in non-dilutive funding in research tax credits from the French government.
IRB protocol approval provides green-light to initiate trial at U.S. clinical sites NEW YORK, April 30, 2020 -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the.
On track to initiate the OPTION 2 trial by the end of Q2 2020OPTION 2 trial to compare efficacy of standard of care to 2.2 and 4.4 gram doses of MS1819 in enteric capsulesTrial.
AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer. When I last wrote to you six months ago (on October 22, 2019), as the newly appointed President and CEO of AzurRx, I spoke about my strong belief in the potential of MS1819, our focus on building shareholder value and in raising sufficient capital to achieve our milestones. Despite COVID-19, we currently anticipate only minor delays in initiating and completing our dose-escalating Phase 2 OPTION 2 monotherapy clinical trial, using 2.2g and 4.4g doses of MS1819 in enteric capsules in the U.S. and Poland.
NEW YORK, April 20, 2020 -- Argus Research, an independent investment research firm, has launched Equity Research Report coverage on AzurRx BioPharma, Inc. (NasdaqCM: AZRX).
Under the terms of the agreement, Delpharm will manufacture AzurRx’s MS1819 cGMP batch that will be used in the Phase 2b OPTION 2 Clinical Trial for the treatment of EPI in patients with Cystic Fibrosis (CF). As preparation for the cGMP batch, the drug product manufacturing process was transferred to Delpharm and they have successfully produced a non-GMP batch.
BROOKLYN, NY / ACCESSWIRE / April 15, 2020 / AzurRx BioPharma, Inc. (NASDAQ:AZRX), is a clinical stage biopharmaceutical company focused on the development of recombinant proteins for the treatment of ...
“Greg is a strong and welcomed addition to our board,” said James Sapirstein, CEO of AzurRx BioPharma. "I am excited to join the AzurRx Board with its compelling potential synthetic alternative to PERT therapy,” said Mr. Oakes. “I look forward to helping the Company realize the full commercial potential of the MS1819 program."
In March 2020, the Company announced it had received $1.13 million for its 2018 CIR for an aggregate total of $1.77 million in non-dilutive funding received in 2020. In addition, the Company anticipates it will receive the 2019 CIR payment by the end of 2020. The CIR has been used to fund AzurRx’s ongoing MS1819 clinical trials, including its Phase 2 Combination therapy study in Cystic Fibrosis.
NEW YORK, NY / ACCESSWIRE / March 18, 2020 / AzurRx BioPharma (NASDAQ:AZRX) will be presenting at this year's Spring Investor Summit on March 25 th -26 th . During the current climate of concern, The Spring ...
The French R&D tax credit initiative (“Crédit d’Impôt Recherche”, or CIR) gives eligible research-based French companies, which are subject to corporate tax in France, the ability to claim tax relief of up to 30% on costs incurred in R&D activities. “The 30% tax relief on R&D activities provides a significant non-dilutive funding source for our on-going research and clinical trial activities in France and Europe through our AzurRx SAS subsidiary,” said James Sapirstein, the CEO of AzurRx. The Research Tax Credit (CIR) is a tax incentive provided by the French Government to encourage the growth of businesses' competitiveness by favoring research and development (R&D) and innovative activities.
The presentation, entitled: “Results from a Phase 2, Open-Label, Multicenter, 2x2 Cross-over Trial to Assess the Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis,” will be delivered by Dr. Michael Konstan, Vice Dean for Translational Research and Professor of Pediatrics at Case Western Reserve University in Cleveland, Ohio. Dr. Konstan will discuss the data from the Company’s Phase II study of MS1819 in patients with cystic fibrosis, which demonstrated safety, a coefficient of fat absorption (CFA) which was similar to the value at the same dose in a prior study in chronic pancreatitis, and positive unexpected findings on the coefficient of nitrogen absorption (CNA).
Alexander Capital, LP acted as sole placement agent in the Offering. Net proceeds from the Offering will be used to eliminate short- and long-term indebtedness, and for general working capital purposes, including product development. The Offering consisted of Senior Convertible Promissory Notes (the “Notes”) and warrants (the “Warrants”) to purchase shares of the Company’s common stock (the “Common Stock”).
Initial data from the first five patients indicate positive trends for all primary and secondary safety and efficacy endpoints in AzurRx’s Phase 2 Clinical Study for MS1819-SD,.
BROOKLYN, N.Y., Jan. 06, 2020 -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant.
NEW YORK, Jan. 03, 2020 -- AzurRx BioPharma, Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies.
Under the purchase agreement, AzurRx will have the right to sell up to $15 million of its stock to Lincoln Park over a 30-month period, upon satisfaction of the conditions in the purchase agreement, including after a registration statement registering the resale of shares to be sold to Lincoln Park under the purchase agreement is declared effective by the Securities and Exchange Commission (SEC). AzurRx, from time to time over a 30 month period, will have the right, at its sole discretion, to sell up to $15 million of its stock to Lincoln Park.
AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from its newly appointed CEO, James Sapirstein. It is with great pleasure that I am writing to you as the new President and Chief Executive Officer of AzurRx BioPharma, Inc. By way of background, I have over 35 years of pharmaceutical industry experience spanning areas such as drug development and commercialization.
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 the Cystic Fibrosis Foundation (CFF) Data Safety Monitoring Board (DSMB) has completed its review of the Company’s final results of the Phase 2 OPTION trial and has found no safety concerns for MS1819-SD. Additionally, the group supports the Company’s plan to proceed to a higher 4-gram dose of MS1819-SD in its next planned Phase 2 clinical trial.
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 dosed the first patients in its Phase 2 clinical trial to investigate MS1819-SD in combination with standard porcine enzyme replacement therapy (PERT) for patients with cystic fibrosis (CF) who suffer from severe exocrine pancreatic insufficiency (EPI).
AzurRx BioPharma, Inc. (AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, is pleased to announce that James Sapirstein has been appointed to serve as the Company’s President and Chief Executive Officer following the resignation of Thijs Spoor from the same positions. Mr. Sapirstein, who most recently served as chief executive officer and board member for ContraVir Pharmaceuticals, Inc. (now known as Hepion Pharmaceuticals, Inc. (NASADQ:HEPA)), has nearly 36 years of pharmaceutical industry experience spanning areas such as drug development and commercialization.
Results showed that the primary efficacy endpoint of coefficient of fat absorption (CFA) was comparable to the CFA in a prior phase 2 study in patients with chronic pancreatitis, while using the same dose of MS1819. The dose used in both studies was 2 gram/day, which was selected in agreement with FDA as a bridging dose. Although the study was not powered for statistical significance, the data also demonstrated meaningful efficacy results, with approximately 50% of the patients showing CFAs high enough to reach non-inferiority with porcine enzyme replacement therapies (PERT).
AzurRx BioPharma, Inc. (AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, reported financial results for the three and six months ended June 30, 2019 and highlighted recent corporate progress. Announced that the first patients were dosed in an open-label, cross-over Phase II OPTION Study with MS1819-SD for exocrine pancreatic insufficiency (“EPI”) in cystic fibrosis (“CF”) in February 2019 and that the study enrollment target was met in May 2019. The Company continues to expect results from the study in September 2019.
BROOKLYN, NY / ACCESSWIRE / July 22, 2019 / AzurRx BioPharma (AZRX), (“AzurRx” or the “Company”), today announced the closing and funding of its previously announced underwritten public offering of five million shares of its common stock at a price to the public of $1.00 per share. The Company also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock, at the public offering price, less underwriting discounts and commissions.