Redhill Biopharma

RedHill Biopharma has initiated patient recruitment for a Phase 2 study evaluating opaganib plus darolutamide in men with metastatic castrate-resistant prostate cancer, sponsored by ANZUP and supported by Bayer.

RedHill Biopharma has received allowance from China's intellectual property authority for a composition-of-matter patent covering RHB-107, strengthening its position in the $3 billion COVID-19 therapeutics market.

New research published in Diabetes, Metabolic Syndrome and Obesity demonstrates opaganib's effectiveness in promoting weight loss and improving glucose tolerance in preclinical models, comparable to semaglutide.

RedHill Biopharma plans to submit Talicia for UK marketing authorization using MHRA's fast-track approval process, with potential approval by Q4 2025.

RedHill Biopharma plans to initiate an innovative Phase 2 study of RHB-204 in MAP-positive Crohn's disease patients, representing a paradigm shift in treatment by targeting a suspected cause rather than symptoms.

RedHill Biopharma has out-licensed RHB-102 to Hyloris in a deal potentially worth up to $60 million plus royalties, strengthening their financial position and development capabilities.

RedHill Biopharma initiates an 80-patient Phase 2 study testing opaganib in combination with Bayer's darolutamide for metastatic castrate-resistant prostate cancer, with financial backing from Bayer and Ramsay Hospital Research Foundation.

• The Crohn's disease market is experiencing growth, driven by increasing prevalence and advances in treatment options, with the market size expected to increase from USD ~9,000 million in 2023. • Emerging therapies like mirikizumab, guselkumab and biosimilars of ustekinumab are showing promise in clinical trials, offering improved efficacy and targeted mechanisms of action for Crohn's disease management. • Pharmaceutical companies such as Eli Lilly, Janssen, Takeda, and Dong-A-ST are actively involved in developing and launching novel treatments, including biologics and biosimilars, to address unmet needs in Crohn's disease. • Clinical trials are focusing on histologic outcomes and endoscopic remission, indicating a shift towards more comprehensive assessments of treatment efficacy in Crohn's disease patients.

RedHill Biopharma and Duke University are collaborating to study opaganib as a countermeasure for phosgene inhalation injury.

RedHill Biopharma has secured U.S. government funding through BARDA to advance the development of opaganib as a medical countermeasure for Ebola virus disease (EBOV).