Welcome to our dedicated page for First Wave BioPharma news (Ticker: FWBI), a resource for investors and traders seeking the latest updates and insights on First Wave BioPharma stock.
First Wave BioPharma, Inc. (FWBI) is a leading biopharmaceutical company dedicated to developing non-systemic, recombinant protein therapies targeting gastrointestinal diseases and related conditions. Headquartered in New York, NY, with scientific operations based in Langlade, France, First Wave BioPharma aims to be at the forefront of innovative treatments in the biotech industry.
The company's flagship development program is MS1819 recombinant lipase, which is in advanced stages of development for treating exocrine pancreatic insufficiency (EPI). This condition often affects patients with cystic fibrosis and chronic pancreatitis, and MS1819 offers a promising alternative to current enzyme replacement therapies.
Besides MS1819, First Wave BioPharma is working diligently on early-stage research projects aimed at preventing hospital-acquired infections, further solidifying its focus on significant unmet medical needs.
In 2024, First Wave BioPharma plans to advance its gastrointestinal (GI) development pipeline significantly. The company expects to add the Phase 3 Latiglutenase celiac disease program and multiple Phase 2 clinical programs featuring Capeserod and Adrulipase. These initiatives are contingent upon the potential merger with ImmunogenX, a deal that could mark a year of substantial growth for the company.
Recent news highlights multiple clinical and development milestones anticipated in 2024, including the initiation of a Phase 3 clinical trial investigating latiglutenase in celiac disease. This trial is pivotal for the company's future, given the significant growth potential it represents in treating celiac disease effectively.
For detailed information and the latest updates, reach out to First Wave BioPharma at their Boca Raton office or through their media contact at Tiberend Strategic Advisors, Inc.
On April 25, 2023, First Wave BioPharma announced significant progress in its Phase 2 SPAN clinical trial for adrulipase, a treatment aimed at exocrine pancreatic insufficiency (EPI) in cystic fibrosis patients. The company has surpassed the 50% enrollment target with three U.S. trial sites actively screening patients. The study is a dose-escalation trial involving 12 patients, focusing on safety, tolerability, and efficacy, with topline results expected in July 2023. Adrulipase is a recombinant lipase enzyme designed to aid fat digestion and reduce malabsorption symptoms. Approximately 40,000 U.S. patients suffer from EPI due to cystic fibrosis.
First Wave BioPharma (NASDAQ: FWBI) announced a private placement agreement to issue 1,023,018 shares of common stock at $3.91 each, raising approximately $4.0 million before fees. The agreement includes warrants for an additional 2,046,036 shares at an exercise price of $3.66, valid for five years. The private placement is expected to close around March 15, 2023, subject to customary conditions. Proceeds will be used for working capital. The company plans to file a registration statement for resale of the shares with the SEC shortly. This offering adheres to SEC regulations, limiting sales to registered entities.
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