|Bid||0.8698 x 1100|
|Ask||0.8700 x 1100|
|Day's Range||0.8522 - 0.9000|
|52 Week Range||0.6500 - 2.6300|
|Beta (5Y Monthly)||1.52|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
AzurRx BioPharma Inc (NASDAQ: AZRX) announced positive interim data from the first 18 out of 20 patients from its Phase 2 trial. The study was evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The interim data revealed that the combination therapy led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption (CFA), with an average gain of 5.9 points from baseline, over the six-week trial. "It is also very encouraging to note that all the patients responded well and that many reported that they felt better overall when MS1819 was added to their daily dose of PERT", said Dr. James Pennington, Chief Medical Officer. Full topline results from all 20 patients enrolled in the trial are expected in the second quarter of 2021. MS1819 is a recombinant lipase enzyme supplied as an oral, non-systemic, biologic capsule derived from the Yarrowia lipolytica yeast lipase. It breaks up fat molecules in the digestive tract of EPI patients to be absorbed as nutrients. Price Action: AZRX shares are trading 8.9% higher at $0.79 during the premarket session on the last check Thursday. See more from BenzingaClick here for options trades from BenzingaPerkinElmer Expands Into Cell Biology With 0M Nexcelom Bioscience AcquisitionCuris Shares Drop On Safety Issues From Leukemia Study With CA-4948; Q1 Earnings Missing Estimates© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
AzurRx BioPharma Inc (NASDAQ: AZRX) has initiated Phase 2 RESERVOIR trial evaluating oral formulation of micronized niclosamide (FW-1022) for the treatment of COVID-19 related gastrointestinal (GI) infections. Patient enrollment is expected to begin soon, with topline data anticipated in Q1 2022. The Phase 2 trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of FW-1022. This trial's two primary objectives will be to confirm the safety of niclosamide and demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract. The trial's primary efficacy measure is the rate of fecal SARS-CoV-2 virus clearance (rectal swab or stool sample), comparing the niclosamide arm to the placebo arm for up to six months. Price Action: AZRX shares are trading 0.95% lower at $0.971 on the last check Tuesday. See more from BenzingaClick here for options trades from BenzingaAzurRx's Stock Falls After MS1819 For Pancreatic Insufficiency Flunks Mid-Stage Study© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
AzurRx BioPharma Inc (NASDAQ: AZRX) reported topline results from its Phase 2b OPTION 2 trial evaluating MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency. MS1819 demonstrated to be safe and well-tolerated. However, the study did not consistently meet the primary efficacy endpoint. Some patients achieved a coefficient of fat absorption (CFA) at levels beyond what is required to demonstrate non-inferiority with porcine enzyme replacement therapy (PERT) therapies, but the majority did not. The company believes that the leading cause of the drug's uneven efficacy performance lies with the enteric capsule formulation. While the enteric coating protects the capsule from breaking down in the stomach acid, it also appears to dissolve too slowly in the small intestine to release the lipase enzyme for proper digestion and nutrient absorption. The company is planning to pursue a new formulation for MS1819, this one a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON, ZENPEP, and other PERT therapies. MS1819 is a recombinant lipase enzyme for treating exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. Price Action: AZRX shares dropped 23.9% at $0.988 in the premarket session on the last check Thursday. See more from BenzingaClick here for options trades from BenzingaBioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study15M Doses Of JNJ COVID-19 Vaccine Batch Ruined After Ingredient Issues At Emergent Biosolutions' US Plant: NYT© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.