Breaking News

Over a month ago
Show Full Stories

X

To view all stories in expanded form, please subscribe.
Send Info
Periodicals
AzurRx BioPharma enters agreement with Creapharm Clinical Supplies » 09:06
05/07/20
05/07
09:06
05/07/20
09:06
AZRX

AzurRx BioPharma

$0.73 /

+0.043 (+6.23%)

AzurRx BioPharma…

AzurRx BioPharma announced that it has entered into an agreement with Creapharm Clinical Supplies for the packaging, labelling and distribution of Phase 2 clinical trial drug product supply of its MS1819 therapy for the treatment of exocrine pancreatic insufficiency. Under the terms of the agreement, Creapharm will package, label, provide qualified person 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. 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.

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.73 /

+0.043 (+6.23%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma receives approx. $721,000 for 2019 CIR » 08:46
05/05/20
05/05
08:46
05/05/20
08:46
AZRX

AzurRx BioPharma

$0.66 /

+0.045 (+7.32%)

AzurRx BioPharma…

AzurRx BioPharma announced AzurRx SAS, its wholly-owned subsidiary in France, has received approximately 661,000 Euros for its 2019 CIR. 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. The French R&D tax credit initiative 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 in France and the European Union. The CIR has previously been used to fund AzurRx's ongoing MS1819 clinical trials in Europe, including its Phase 2 Combination therapy study in Cystic Fibrosis.

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.66 /

+0.045 (+7.32%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma receives IRB approval to start Phase 2 OPTION 2 trial » 08:33
04/30/20
04/30
08:33
04/30/20
08:33
AZRX

AzurRx BioPharma

$0.63 /

+0.04 (+6.78%)

AzurRx BioPharma…

AzurRx BioPharma announced that it has received Institutional Review Board approval of its Phase 2 OPTION 2 clinical trial protocol to investigate MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency.

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.63 /

+0.04 (+6.78%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma receives approval to conduct Phase 2 OPTION 2 trial » 08:10
04/29/20
04/29
08:10
04/29/20
08:10
AZRX

AzurRx BioPharma

$0.59 /

+ (+0.00%)

AzurRx BioPharma…

AzurRx BioPharma announced that the Company received approval to conduct of its Phase 2 OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency in Therapeutics Development Network clinical sites. The TDN is a collaborative network of CF clinical trial specialists supported by the Cystic Fibrosis Foundation. TDN support allows for access to 91 accredited U.S. care centers with established expertise in CF clinical research that facilitate recruitment and implementation of studies. The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of MS1819 using 2.2 and 4.4 gram doses in enteric capsules head-to-head against the current standard of care, porcine pancreatic enzyme replacement therapy pills. The study is expected to enroll 30 CF patients with target enrollment expected in Q4 2020 and study completion anticipated in Q1 2021.

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.59 /

+ (+0.00%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma discontinues AZX1103 beta-lactamase, MTAN pre-clinical programs » 08:17
04/21/20
04/21
08:17
04/21/20
08:17
AZRX

AzurRx BioPharma

$0.64 /

+0.01 (+1.59%)

CEO James Sapirstein…

CEO James Sapirstein said, "We have made considerable progress in strengthening our balance sheet, realigning and reducing operating expenses and improving our financial controls. In November 2019, we entered into a purchase agreement for a $15M equity line of credit with Lincoln Park Capital Fund, a Chicago-based institutional investor and a long-standing investor in AzurRx. This has provided us with access to sufficient capital to move forward with our two Phase 2 clinical trials for MS1819. As a follow up to the Lincoln Park equity line, in December 2019 and January 2020, we closed a $6.9M private placement consisting of senior convertible promissory notes and warrants. The convertible notes are convertible into common stock at $0.97 per share, accrue interest at 9% per annum and mature on September 20, 2020. Many of our long-standing investors participated in this round, and we greatly appreciate their continued support of AzurRx. With these funds, we have been able to continue investing in our clinical trials - by funding both the combination therapy study in Europe and preparations for the upcoming OPTION 2 monotherapy study in the United States and Poland. Simultaneous to our fundraising efforts, we also significantly reduced our liabilities - by restructuring and paying off most of our short-term obligations, including accounts payable and promissory notes. In addition, in Q1 2020, we received an aggregate total of $1.77M in non-dilutive funding from our French R&D tax credit for the years 2017 and 2018. We anticipate receiving our 2019 CIR towards the end of the year. Finally, in April 2020, we received a CARES Act Paycheck Protection Program loan of approximately $180,000 through the Small Business Administration. This loan, which may be forgivable, will be used to pay employees and other eligible expenses such as rent during the COVID-19 crisis. Upon joining AzurRx, one of my first objectives was to hire a new financial team to both improve our financial controls and bring them fully in-house. As mentioned above, in Q1 2020 we hired a new CFO and Controller and they have rationalized our budgeting process, introduced cost saving measures, and introduced the appropriate controls across our U.S. and French operations. As part of our strategic review, we made the decision to discontinue both our AZX1103 beta-lactamase and MTAN pre-clinical programs in order to fully concentrate our resources on the development of MS1819. As a result of these efforts, we have been able to reduce our monthly expenses, while continuing to advance our clinical programs for MS1819. Our workforce has successfully transferred to a work-at-home setting, and I would also like to emphasize that our progress and clinical trial preparations are continuing even in the current COVID-19 environment."

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.64 /

+0.01 (+1.59%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma says taken steps to strengthen team, streamline operations » 08:15
04/21/20
04/21
08:15
04/21/20
08:15
AZRX

AzurRx BioPharma

$0.64 /

+0.01 (+1.59%)

CEO James Sapirstein…

CEO James Sapirstein said, "We have taken several steps to strengthen our team, broaden our talent pool and consolidate and streamline our operations: Finance: hiring Daniel Schneiderman as our CFO and a new Controller; Clinical Operations: consolidation of all U.S.-European clinical trial programs under Jim Pennington, M.D., our CMO; Chemistry, Manufacturing & Controls: hiring Ted Stover to serve as global Product Development Manager for MS1819; and Board of Directors: appointing Greg Oakes, a seasoned biotech executive with significant experience and a track record in pharma commercialization and partnering."

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.64 /

+0.01 (+1.59%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma says supply chain has not been impacted by COVID-19 » 08:13
04/21/20
04/21
08:13
04/21/20
08:13
AZRX

AzurRx BioPharma

$0.64 /

+0.01 (+1.59%)

CEO James Sapirstein…

CEO James Sapirstein said, "Earlier this month we signed a manufacturing agreement with Delpharm, a leading contract development manufacturing organization, for the clinical drug supply of MS1819 for the OPTION 2 clinical trial scheduled to initiate in Q2 2020. This marks the first time that MS1819 will be manufactured with enteric capsules, which we believe should prevent the MS1819 lipase from breaking down prior to reaching the duodenum so that substantially more drug product can be released. Our supply chain remains intact and, as of today, has not been impacted by COVID-19. Relatedly, COVID-19 highlights both the health risk of animal pathogens in medicinal products and the risk of supply chain disruption, when animals are either quarantined or culled. For example, in 2019 the Chinese government ordered the culling of half of their pig population following a swine flu epidemic. Chinese pigs are the source of a majority of the world's porcine pancreases used in pancreatic enzyme replacement therapy products. In contrast, MS1819 is a synthetic recombinant yeast that can be safely and reliably produced in fermenters under the strictest quality control."

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.64 /

+0.01 (+1.59%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma expects interim data from Phase 2 combination trial in Q3 » 08:12
04/21/20
04/21
08:12
04/21/20
08:12
AZRX

AzurRx BioPharma

$0.64 /

+0.01 (+1.59%)

CEO James Sapirstein…

CEO James Sapirstein said, "In Q4 2019 we dosed the first patient in our Phase 2 combination therapy clinical trial in Hungary. In January 2020 we reported that the data from the first five patients in the study, for primary and secondary efficacy endpoints, was positive and that there were no safety issues. We are completing the trial in sites in Hungary and plan to open new trial sites in Spain, and possibly in Turkey, in Q3 2020. We plan to release interim data during Q3 2020, anticipate completion of the Combination Trial by the end of 2020 and top line data in Q1 2021. Although we are very pleased with our current clinical trial progress, the impact of COVID-19 on clinical trials changes on a daily basis and could in the future impact the progress of our trials. We intend to provide updates if required as the COVID-19 pandemic continues to develop."

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.64 /

+0.01 (+1.59%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma expects minor delays in Phase 2 OPTION 2 clinical trial » 08:10
04/21/20
04/21
08:10
04/21/20
08:10
AZRX

AzurRx BioPharma

$0.64 /

+0.01 (+1.59%)

CEO James Sapirstein…

CEO James Sapirstein said, "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. During Q1 2020, we executed contracts with our clinical research organizations and began preparation for the trial, including identifying the trial sites and investigators. In addition, the clinical trial protocol has been reviewed by the FDA with no comments, and we intend to begin Institutional Review Board reviews shortly. Barring any significant coronavirus developments, we should be able to initiate the OPTION 2 Trial by the end of Q2 2020 and expect top line data in Q1 2021."

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.64 /

+0.01 (+1.59%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities
Hot Stocks
AzurRx BioPharma CEO reiterates 'firm, continued belief' in MS1819 » 08:09
04/21/20
04/21
08:09
04/21/20
08:09
AZRX

AzurRx BioPharma

$0.64 /

+0.01 (+1.59%)

AzurRx BioPharma issued a…

AzurRx BioPharma issued a letter to its shareholders and the investment community from James Sapirstein, President and CEO. The letter said, in part, "I hope that all is well with you and your families during these difficult and unprecedented times of the COVID-19 pandemic. When I last wrote to you six months ago, 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. I am pleased to say we have made progress towards all of these goals. Let me now provide a more detailed update on our progress and share with you our goals for 2020 and 2021, including our plans to develop MS1819 into a Phase 3 ready asset that can potentially be monetized..I would like to reiterate my firm and continued belief in the potential for MS1819 as we remain focused on building shareholder value and executing upon our corporate objectives and milestones. We believe that the successful completion and release of key efficacy data from the Phase 2 monotherapy and combination therapy trials in Q1 2021 represent inflection points that can increase the value of AzurRx and provides the fundamental basis for developing MS1819 into a Phase 3 ready asset. In addition to executing on our clinical studies and releasing data, we plan to spend 2020 and early 2021 focusing on the necessary CMC and regulatory objectives needed to fully develop MS1819 for Phase 3 and commercialization. To that end, we are planning for a new manufacturing campaign to optimize our long-term drug supply chain and evaluate process improvements to further reduce manufacturing costs. Additionally, this campaign will support the toxicity studies needed to provide the clinical drug supply necessary to initiate our Phase 3 trial. Finally, we will be drafting a pediatric study plan to support a successful end of Phase 2 meeting with the FDA. I believe achieving these clinical, CMC and regulatory milestones are critical in order to maximize the value of AzurRx and reward the patience and support of our investors and stakeholders."

ShowHide Related Items >><<
AZRX AzurRx BioPharma
$0.64 /

+0.01 (+1.59%)

06/11/19 National Securities
AzurRx BioPharma initiated with a Buy at National Securities

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.