RedHill Biopharma

RedHill plans to submit UK MAA 1  for Talicia for H. pylori infection, using MHRA's 2  new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG 3  Clinical Guideline as a first-line option, Talicia is the leading branded H.» Mehr auf prnewswire.com

The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on path to FDA approval, with FDA guidance expected in Q2/25 -- Patent protected until 2041, RHB-204 is a next generation anti-MAP therapy derivative of RHB-104 3  which successfully met its groundbreaking Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus SoC and showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes -- Based on insights from RHB-104's statistically significant positive Phase 3 study results, the improved formulation RHB-204 is designed to reduce pill burden and further enhance tolerability, safety and adherence, and along with the uniquely defined patient population (MAP-positive), allows for a study design with a small sample size and decisive endpoints, entailing lower study costs and expedited timeframe -- The role of MAP as a cause of CD, to be tested in this study, supports a paradigm-shifting new therapeutic approach for CD – focused on addressing the actual cause of the disease, not the symptoms -- The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033, presenting significant commercial potential for a new FDA approved therapy RALEIGH, N.C.» Mehr auf prnewswire.com

Guy Goldberg, RedHill's Chief Business Officer, presents today a business update at the European Life Sciences CEO Forum The update covers: The recent out-licensing of RHB-102 [1] to Hyloris (Euronext Brussels: HYL) in a potential $60 million plus royalties deal Initiation of the Bayer-funded Phase 2 clinical study of opaganib [2] in combination with Bayer's (ETR: BAYN) darolutamide in advanced prostate cancer Status of the U.S. government-supported pipeline programs and expected 2025 catalysts Significant commercial progress with Talicia®: Additional marketing authorization applications in new markets being evaluated Discussions ongoing focused on significant cost of goods (COGs) reduction Inclusion as first-line option for treatment of H. pylori infection in American College of Gastroenterology (ACG) Clinical Guideline Humana®'s Part D Plan coverage adds access for more than eight million additional Medicare lives, without prior therapeutic steps or authorization Surpassed 100,000 prescriptions milestone, maintaining position as the #1 brand prescribed by gastroenterologists Ground-breaking warranty program launched - minimal claimed refunds New data on more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine published in the Journal of Clinical Pharmacology supporting prior FDA sNDA approval for TID dosing Out-license, approval and launch in the United Arab Emirates RALEIGH, N.C.» Mehr auf prnewswire.com