AzurRx BioPharma Inc. AZRX Archives - Page 4 of 4

TuesdayNov 10, 2020 11:12 am

QualityStocksNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Enters LOI with Asymchem for MS1819 Development, Production

AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced its entry into a binding letter of intent (“LOI”) with Asymchem, a leading global contract development and manufacturing service (“CDMO”) provider, for the development and production of MS1819 for the treatment of exocrine pancreatic insufficiency. Under the agreement, Asymchem will implement fermentation, verify protein expression and ultimately fine-tune the technology suitable for production of MS1819. Asymchem will be responsible for sourcing all materials required for the program under Current Good Manufacturing Practice (“cGMP”) regulatory conditions. “With a fairly competitive landscape for CDMOs,…

MondayNov 02, 2020 11:49 am

QualityStocksNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Secures $6.9M in Private Placement

AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, earlier this year announced the closing of a private placement financing (the “offering”). According to the update, AzurRx secured approximately $6.9 million in gross proceeds from certain accredited investors, with Alexander Capital LP acting as sole placement agent in the offering. The company intends to use net proceeds to eliminate short- and long-term indebtedness, as well as for general working capital purposes including product development. “We are very grateful for the continued support of our investors,” James Sapirstein, president and CEO of AzurRx said…

WednesdayOct 28, 2020 12:22 pm

QualityStocksNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Secures Financing to Fund Phase 2 Clinical Trials and Phase 3 Preparations

AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company, in July entered into a convertible preferred stock and warrant securities purchase agreement with certain accredited and institutional investors relating to the private placement of certain shares of convertible preferred stock and warrants for cash and in exchange for certain outstanding promissory notes as described in a recent update. In addition, the company entered into an exchange addendum to the purchase agreement with certain investors, relating to the exchange, as consideration in the private placement, of approximately $6.9 million aggregate in principal amount, plus all accrued and unpaid interest thereon, of its outstanding…

TuesdayOct 27, 2020 1:52 pm

QualityStocksNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Announces Positive Results in Ongoing Phase 2 Combination Therapy Trial with MS1819

AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company, recently announced positive results from the first five patients in its Phase 2 combination therapy trial of MS1819 for the treatment of severe exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”). In the primary efficacy analysis, patients receiving MS1819 in combination with PERT therapy achieved a clinically meaningful improvement in the coefficient of fat absorption (“CFA”) at each of the three dose levels. No adverse safety events were reported and, additionally, patients showed improvements in the key secondary endpoints, including body weight, stool consistency and reductions in the number of bowel…

WednesdayOct 21, 2020 10:53 am

QualityStocksNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Forms New Scientific Advisory Board

AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company focused on developing treatments for gastrointestinal diseases using recombinant proteins, has announced the formation of a Scientific Advisory Board (“SAB”) designed to provide the company with invaluable expertise and insights. The company also announced that three leading global experts in exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis and chronic pancreatitis have been appointed to the board: Michael Konstan, MD; Darwin L. Conwell, MD; and Michael Wilschanski, MD. Konstan is vice dean for translational research and the Gertrude Lee Chandler Tucker Professor of Pediatrics at Case Western Reserve University School of Medicine; he…

ThursdayOct 15, 2020 12:23 pm

AzurRx BioPharma Inc. (NASDAQ: AZRX) is “One to Watch”

AzurRx BioPharma’s lead therapeutic, MS1819, is a recombinant lipase treatment for exocrine pancreatic insufficiency and is currently targeting patients with cystic fibrosis and chronic pancreatitis – an established global market of more than $2 billion The company is currently pursuing parallel monotherapy and combination therapy trials, which are anticipated to produce topline data in Q1 2021 and Q2 2021, respectively Previously completed clinical trials of MS1819 showed primary and secondary endpoint efficacy, with a positive safety profile To fully finance its ongoing Phase 2 trials and being preparations for a pivotal Phase 3 study in 2021, as well as to…

WednesdayOct 14, 2020 10:40 am

QualityStocksNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Adds More Sites for Cystic Fibrosis Clinical Trials

AzurRx BioPharma (NASDAQ: AZRX) has activated additional clinical trial sites for its trial of MS1819 in cystic fibrosis. The company specializes in the development of nonsystemic, recombinant therapies for gastrointestinal diseases. The company has activated two additional trial sites in Turkey for its Phase 2 combination therapy trial of its lead drug candidate, MS1819. MS1819 is a recombinant lipase for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients suffering from chronic pancreatitis and cystic fibrosis. Patient screening has already been initiated for the new trial sites, with topline data expected by Q2 2021. AzurRx had previously activated six clinical sites in Hungary,…

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