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AzurRx BioPharma, Inc. rebrands to First Wave BioPharma, Inc. and will trade under the new ticker symbol FWBI starting September 22, 2021, on Nasdaq. This change follows the acquisition of First Wave Bio, Inc., completed on September 13, 2021, enhancing the Company’s gastrointestinal therapeutic pipeline with six clinical programs. CEO James Sapirstein emphasized expectations for improved long-term prospects and shareholder value. For comprehensive details, refer to the Company's Current Report on Form 8-K, filed on September 13, 2021.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) has announced its acquisition of First Wave Bio, Inc., effective September 13, 2021. This merger will facilitate the company's transition to the new name, First Wave BioPharma, with a ticker change to FWBI on September 23, 2021. The acquisition focuses on developing targeted therapies for gastrointestinal diseases, notably leveraging niclosamide for inflammatory bowel disease (IBD) treatments. Financially, the deal includes $3 million in cash and $4 million in shares, alongside milestone payments. The company's pipeline now encompasses six GI indications with substantial market potential.
AzurRx BioPharma has announced a definitive agreement to acquire First Wave Bio for $229 million, transforming into First Wave BioPharma and changing its NASDAQ ticker from AZRX to FWBI. This acquisition expands AzurRx's gastrointestinal (GI) therapeutic pipeline, introducing three new clinical indications for inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease. The company expects strong growth and increased shareholder value from this strategic move targeting significant market opportunities in the GI space.
AzurRx BioPharma (NASDAQ: AZRX) announced a 1-for-10 reverse stock split effective on September 13, 2021. This decision, approved by stockholders earlier, aims to enhance the company's market presence and attract institutional investors.
Post-split, shares will reduce from approximately 93 million to 9.3 million, but ownership percentages will remain unchanged. The reverse split is part of a long-term strategy to meet NASDAQ listing requirements and improve liquidity.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) announced the activation of seven new clinical trial sites in India for its Phase 2 RESERVOIR trial, aimed at evaluating the safety and efficacy of FW-1022, a niclosamide formulation for treating COVID-19-related gastrointestinal infections. This expands the total number of trial sites to 23, including locations in the U.S. and Ukraine. Topline results are expected in the first quarter of 2022. The trial targets SARS-CoV-2 clearance from the GI tract, addressing an urgent need in the ongoing pandemic.
AzurRx BioPharma (NASDAQ: AZRX) announced that the independent data monitoring committee has approved continuing to Part 2 of the RESERVOIR Phase 2 clinical trial for FW-1022. This trial will evaluate the efficacy of the oral formulation of micronized niclosamide in treating COVID-19-related gastrointestinal infections. Up to 150 patients will be enrolled in the U.S., Ukraine, and India. Topline results are expected in Q1 2022, following a favorable review of safety data from nine patients in Part 1. The study aims to confirm FW-1022's safety and its ability to clear SARS-CoV-2 from the GI tract.
AzurRx BioPharma (NASDAQ: AZRX) has submitted an IND Application to the FDA for a Phase 1b/2a clinical trial to evaluate the safety and efficacy of FW-420 in treating immune checkpoint inhibitor-associated colitis in cancer patients. The trial aims to assess both oral and topical formulations of niclosamide for Grade 1 and 2 colitis and diarrhea. The company is also exploring FW-1022 for gastrointestinal infections related to COVID-19. This trial is crucial due to the significant incidence of colitis in patients undergoing immunotherapy, with no approved treatment available for Grade 1 colitis.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CEO James Sapirstein's prerecorded presentation starts at 9:00 a.m. ET on September 13, focusing on the company's gastrointestinal therapies and upcoming milestones for 2021 and early 2022. The management team will also hold virtual one-on-one meetings with investors and pharmaceutical executives. For more details, visit the conference's registration link.
AzurRx BioPharma announced positive topline results from its Phase 2 Combination Trial for MS1819, combined with PERT, to treat severe Exocrine Pancreatic Insufficiency (EPI) in cystic fibrosis patients. The trial, involving 20 participants, showed a clinically meaningful improvement in Coefficient of Fat Absorption (CFA), with an average increase of over 6 percentage points. Additionally, the study indicated weight gain and positive outcomes on secondary endpoints. The company plans to finalize a new enteric-coated microbead formulation of MS1819 by year-end, enhancing its therapeutic potential.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) announced that the World Health Organization has proposed "adrulipase alfa" as the International Nonproprietary Name for MS1819, a recombinant lipase enzyme aimed at treating exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. This designation signifies validation in its development process and differentiation from current therapies. The company expects to release full results from its Phase 2 combination therapy trial by Q3 2021, with WHO's final decision on adrulipase alfa expected by November 2021.
