RDHL News & Events

RedHill Biopharma announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis, or MAP, killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs MAP-targeted therapeutic approach to the treatment of Crohn's disease, or CD. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects. A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. RedHill is actively pursuing partnerships and collaborations for this program, in addition to non-dilutive external funding sources. The development of RHB-204 is supported by published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy.

RedHill Biopharma announced the independent presentation of new preclinical data at the 2026 American Association for Cancer Research, or AACR, Annual Meeting, showing positive effects of opaganib as potential add-on therapy in models of neuroblastoma, or NB, and triple-negative breast cancer, or TNBC. The positive NB data, from studies undertaken by Penn State University's Jeremy Hengst, and Apogee Biotechnology funded by the Beat Childhood Cancer Foundation and Four Diamonds, indicate that opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin, or OXDOX, chemotherapy combination in high-risk NB. The data showed that opaganib directly destabilized n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, regulating cell proliferation, differentiation, and apoptosis during embryonic development, a critical factor driving poor outcomes. A second poster from the University of Kansas' Colette Worcester describes in vitro model data showing that pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the poorest prognosis of the breast cancer subtypes. Neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0-14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S. Opaganib received FDA Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, a rare pediatric cancer, with potential for a Rare Pediatric Disease Priority Review Voucher.

RedHill Biopharma (RDHL) announced that the full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings, or THI, and Cumberland Pharmaceuticals (CPIX), has started and is now being rolled out to support accelerated market penetration and expanded reach. This marks the operational launch of the joint commercialization model previously announced in October 2025, including Cumberland's $4M strategic investment. "H. pylori infection affects 35% of the U.S. adult population and is a leading cause of gastric cancer, responsible for approximately 11,000 related U.S. deaths a year," said Rick Scruggs, President of THI and RedHill's COO. Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy designed to address growing antibiotic resistance concerns to other available therapies. It is listed as a first-line H. pylori treatment option in the 2024 American College of Gastroenterology Clinical Guideline, which emphasizes using 14-day, "optimized" regimens for the first attempt to maximize cure rates and avoid the need for complex, less-effective salvage therapies4. It is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation. Talicia is also the only FDA-approved medication for H. pylori infection with an all-in-one formulation, with the added benefit of simple dosing. RedHill continues to work towards expanding patient access to Talicia globally. Efforts focused on potential new market entries in the UK and the Middle East, along with work to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams, are ongoing.

RedHill Biopharma announced development progress for RHB-102 in multiple GI indications, including its development, via the accelerated FDA 505(b)(2) route, as a once-daily oral ondansetron therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects, such as nausea, vomiting and diarrhea, that are estimated to significantly limit growth in the multi-billion-dollar GLP-1 market. RedHill further announced that it is currently pursuing potential U.S. FDA approval of RHB-102 for oncology support, with additional potential for use in post-operative nausea and vomiting. If approved by FDA, RHB-102 could be the first oral 24-hour extended-release ondansetron antiemetic drug for the treatment of CINV/RINV. Expansion of RHB-102's intellectual property coverage for relevant indications, including GLP-1-associated nausea and vomiting, has also advanced.