|Bid||1.1100 x 2200|
|Ask||1.1200 x 3000|
|Day's Range||1.0150 - 1.3299|
|52 Week Range||1.0000 - 3.7500|
|Beta (3Y Monthly)||2.25|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
The effort will examine combination use of MS1819-SD and pancreatic enzyme replacement therapy (PERT) for cystic fibrosis (CF) patients with severe exocrine pancreatic insufficiency (EPI). This is a subset of CF patients that are suffer from malnutrition and fail to absorb sufficient fat despite taking the maximum dose of PERT therapy. The new study will be conducted at six sites in Hungary with an enrollment target of 28.
We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly...
On May 20th AzurRx BioPharma, Inc. (AZRX) presented secondary endpoint results for its Phase II Chronic Pancreatitis (CP) study, which completed clinical work in June 2018. The update follows topline and primary endpoint results released from the same trial last fall, which found a coefficient of fat absorption of 21.8% statistically significant to a p value of 0.002. The MS1819-SD Phase 2a open-label, dose escalation study was conducted in France, Australia and New Zealand.
Highlights for the year and to date include participation in investment conferences, the addition of Dr. James Pennington as CMO, presentation of favorable trial data from chronic pancreatitis patients, the launch of the cystic fibrosis trial, and acquisition of rights from Protea and Mayoly. Research and development expenses were up 108% compared to the prior year period.
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...
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.
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.