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AzurRx BioPharma (NASDAQ: AZRX) announced the dosing of two patients in the Phase 2b OPTION 2 extension study of MS1819, aimed at treating exocrine pancreatic insufficiency in cystic fibrosis patients. This study explores higher doses of MS1819 using immediate-release capsules and follows a successful initial crossover trial. The Data Monitoring Committee has expressed no safety concerns. Topline results are expected in Q1 2021, and AzurRx is preparing for a key FDA meeting later this year.
AzurRx BioPharma announced a patent allowance for niclosamide to treat COVID-19 gastrointestinal infections, addressing a significant unmet clinical need. The U.S. market for this treatment could reach $450-$600 million within its first year, depending on pandemic control. A Phase 2 clinical study is planned for the first half of 2021. Approximately 18% of COVID-19 cases involve GI symptoms, translating to 3.4 million U.S. patients. The company believes its formulation can reduce viral load in the GI tract, improve symptoms, and reduce transmission.
AzurRx BioPharma (NASDAQ: AZRX) is optimistic as it enters 2021, citing its achievements despite challenges faced last year. The company announced an in-licensing agreement with First Wave Bio for new gastrointestinal (GI) indications, enhancing its portfolio. AzurRx is poised for growth with three clinical assets targeting the significant unmet needs in the GI market. The lead program, MS1819, is on track to deliver top-line data in Q1 and Q2 of 2021, with potential market value exceeding $1.4 billion in the U.S. New trials for micronized niclosamide are expected to start, targeting immune checkpoint inhibitor colitis and COVID-19 GI infections.
AzurRx BioPharma (NASDAQ: AZRX) will participate in the Biotech Showcase Digital 2021 conference from January 11-15, 2021. James Sapirstein, President & CEO, alongside the senior management team, will engage in virtual one-on-one meetings with investors to discuss the company's business and clinical development programs, highlighting anticipated milestones for 2021. AzurRx specializes in developing targeted therapies for gastrointestinal diseases, including its lead candidate MS1819 for treating exocrine pancreatic insufficiency.
AzurRx BioPharma (NASDAQ: AZRX) is participating in the H.C. Wainwright BioConnect 2021 Conference from January 11-14, 2021. CEO James Sapirstein will engage in one-on-one virtual meetings with investors and pharmaceutical companies, discussing the company's business and clinical development plans. AzurRx specializes in non-systemic therapies for gastrointestinal diseases, with ongoing Phase 2 trials for its lead asset, MS1819, and two other therapies targeting immune-related colitis and COVID-19 gastrointestinal infections.
AzurRx BioPharma (NASDAQ: AZRX) will participate in the 10th Annual LifeSci Partners Corporate Access Event from January 6-8 and 11-14, 2021. James Sapirstein, President & CEO, will engage in virtual one-on-one meetings with investors and pharma companies, discussing the company’s business, clinical programs, and upcoming milestones for 2021. AzurRx focuses on innovative, non-systemic therapies for gastrointestinal diseases, with key products targeting exocrine pancreatic insufficiency and COVID-19 gastrointestinal infections.
AzurRx BioPharma (NASDAQ: AZRX) has entered an exclusive licensing agreement with First Wave Bio for niclosamide, targeting immune checkpoint inhibitor-associated colitis and COVID-19 gastrointestinal infections. This strategic move aims to enhance AzurRx's pipeline focusing on gastrointestinal therapies. The agreement includes a $10.25 million upfront payment and potential milestone payments of up to $74 million, alongside royalties on product sales. Clinical trials are set to begin in the first half of 2021, with management discussing the developments in a scheduled conference call.
AzurRx BioPharma (NASDAQ: AZRX) announced entering into a licensing agreement with First Wave Bio, alongside a securities purchase agreement with a healthcare-focused institutional investor. The company plans to sell approximately $8 million of Series C 9.00% Convertible Junior Preferred Stock, and issue unregistered warrants to purchase up to 10,666,668 common stock shares. Proceeds will fund the licensing agreement and general corporate purposes. The offering is subject to stockholder approval for certain share issuances. Closing is expected on January 5, 2021.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) has dosed its first patients in Turkey for the Phase 2 Combination Trial evaluating MS1819 with standard pancreatic enzyme therapy for cystic fibrosis patients suffering from severe exocrine pancreatic insufficiency (EPI). The drug aims to improve fat absorption and thus enhance quality of life. Topline data is expected in Q2 2021. The trial, being conducted across multiple centers, has already shown positive results in initial patients, indicating potential to improve body weight and reduce bowel-related issues.
AzurRx BioPharma (NASDAQ:AZRX) announces a protocol amendment for its Phase 2b OPTION 2 trial of MS1819, targeting exocrine pancreatic insufficiency in cystic fibrosis patients. The amendment proposes adding a study arm using immediate release capsules to compare it against the current delayed release version. The trial is ahead of schedule and nearly fully enrolled without safety issues. If FDA-approved, enrollment for the new arm could start in December 2020, with top-line data expected in Q1 2021, reflecting potential for additional clinical insights.
