RedHill Biopharma Acquires Rebyota and Clenpiq for GI Drug Portfolio Expansion

TEL AVIV, Israel and RALEIGH, N.C., Sept. 30, 2026 /CourierPR/ -- RedHill Biopharma, a specialty biopharmaceutical company, has announced significant operational highlights and financial results for the six months ended June 30, 2026. The company has executed a strategic portfolio reset, acquiring commercialization rights to Rebyota® and Clenpiq®, two FDA-approved gastrointestinal (GI) drugs, for a total of $12 million upfront payment. This transaction was fully funded by the $18 million received from the divestment of RedHill's 70% stake in Talicia, which generated up to $35 million in potential worldwide net sales milestones.

RedHill's lean commercial infrastructure, which is well-established within the U.S. GI market, will now support the rapid and smooth transition of Rebyota® and Clenpiq® into the company. These two drugs generated approximately $37.5 million in 2025 net sales under Ferring Pharmaceuticals. Rebyota® is a single-dose Fecal Microbiota Transplant (FMT) approved for the prevention of recurrent Clostridioides difficile (C. diff) infection in individuals 18 years of age and older following antibiotic treatment for rCDI. C. diff infection is a distressing and life-threatening condition, being the most common cause of healthcare-associated (HA) diarrhea in developed countries. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. Thirty thousand Americans die every year due to CDI, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences, indicating the need for use of prevention strategies. Rebyota's one-time administration, which requires no fasting, bowel prep, or extended treatment timeframe, has demonstrated more than a 70% success rate at preventing rCDI. The existing approvals also provide the potential for additional approvals in other territories.

Clenpiq, a ready-to-drink, low-volume bowel preparation, delivered $20.6 million in net sales in 2025. Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually. This number is rising, with follow-up needed after noninvasive screening tests that yield a positive result, an aging population, and guidelines that recommend testing at age 45 instead of age 50, contributing to an increased need for colonoscopy. Bowel preparation quality drives outcomes and cost, but it is not a pleasant process and is often poorly performed, driving the need for repeated procedures. Clenpiq has broad commercial and government payer coverage, making its benefits readily accessible to patients: More than 108 million lives (63%) with unrestricted (no prior approval) have commercial coverage, including 57 million (33%) with preferred position. Twenty-three million lives (41%) of Medicare Part D lives have unrestricted access to Clenpiq, including 12 million (21%) lives with preferred position.

RedHill's focused and advanced R&D pipeline includes opaganib, which has been granted U.S. Food and Drug Administration (FDA) rare pediatric disease designation for neuroblastoma, the most prevalent cancer in infants. This designation provides potential for an accompanying Priority Review Voucher (PRV). New preclinical data showed positive effects of opaganib as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC). Two sets of data presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting indicate that opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin (OXDOX) chemotherapy combination in high-risk NB by directly destabilizing n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, through increased ceramide production enhancing programmed cell death (apoptosis) in cancer cells. 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.

In Crohn's disease, new RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-104. RHB-204 achieved these results with lower doses of key active ingredients, enhancing potential for reduced toxicity and side effects, supporting an innovative FDA-aligned Phase 2-ready study design allowing for a smaller sample size, lower study costs, and faster time to completion.

Financial results for the six months ended June 30, 2026, showed no revenues, compared to $0.3 million in the first half of 2025, which was generated from the Hyloris license agreement for RHB-102 (Bekinda®). Research and development expenses for the first half of 2026 were $1.0 million, unchanged from the first half of 2025. General, administrative, and business development expenses for the first half of 2026 were $2.5 million, compared to $2.7 million for the first half of 2025. The decrease was primarily attributable to lower professional services expenses and the allocation of certain costs to THI following the transfer of Talicia commercial operations. Share of loss of joint venture for the first half of 2026 was $0.