Redhill Biopharma

RDHL

Market cap $5.19M

Amid the rapidly evolving Ebola virus disease (EVD) outbreak involving the rare Bundibugyo ebolavirus sub-type, for which there are no approved medications or vaccines, RedHill Biopharma is actively discussing potential collaborations for clinical advancement of opaganib 1 , including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform Opaganib EVD rationale (analogous to EVD treatment pathway): Phase 3 clinical antiviral activity (severe COVID-19) showing 2 : 70.2% mortality reduction with opaganib given as add-on to best available standard of care (remdesivir + corticosteroids): 6.98% (n=3/43) opaganib + SoC vs. 23.4% (n=11/47) placebo + SoC (p=0.034)) Improved median time to viral RNA clearance by ≥4 days in opaganib-treated patients (median 10 days vs.

Vancouver, BC, May 26, 2026 (GLOBE NEWSWIRE) -- Bessor Minerals Inc. (TSXV:BST) ("Bessor" or the “Corporation”) announces that, on February 9, 2026, it entered into an agreement (the “Agreement”) with Homegold Resources Ltd. (“Homegold”) and Johan Shearer (“Shearer”), pursuant to which Bessor terminated its option to acquire a 100% interest in the Redhill property, located south of Ashcroft, B.C (the "Redhill Property") in exchange for a 30% ownership interest in the Redhill Property (the “30% Ownership Interest”). Under the Agreement, Shearer and Homegold are at liberty to deal with Bessor's 30% Ownership Interest in the Redhill Property in their sole discretion, without the prior written consent of Bessor and Bessor will be entitled to a 30% share of any gross proceeds from such sale or disposition.

RHB-2041 is a next-generation optimized formulation of RedHill's oral RHB-104 2 , designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD) In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048) 3 New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1044 . Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease.

2025 was a year of tenacity, strategic transactions and building traction for RedHill Talicia® business transformed: Formation of Talicia Holdings Inc. (THI) and the U.S. co-commercialization partnership with Cumberland Pharmaceuticals ("Cumberland") (Nasdaq: CPIX), including Cumberland's $4 million investment for a 30% equity interest in THI planned to drive Talicia growth, and potentially additional revenue generating products. Cumberland and Apotex 1 , Canadian-based global health company, have since announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex Added eight million lives with coverage by Humana®'s Part D Plan and published new data supporting Talicia's FDA-approved label change to a more convenient three-times daily Talicia dosing routine Expanded Talicia activities in the Middle East, which included licensing for new Middle East markets, generated revenue of approximately $1.9 million in 2025 within discontinued operations  Targeting Talicia global market expansion in the UK with submission of fast-track Marketing Authorisation Application (MAA) imminent R&D pipeline focus and progress: RHB-204 for Crohn's disease (CD) advancing in accordance with FDA feedback on its pathway to approval as well as two new lab collaborations signed with work ongoing for MAP killing preclinical testing and development of rapid and accurate detection diagnostics  Opaganib's potential as a key add-on therapy in oncology progressing with a Phase 2 combination study of opaganib and darolutamide (Bayer' fast growing blockbuster drug) in advanced prostate cancer (mCRPC), with expanded sites and ongoing recruitment; Additionally, new preclinical data supporting opaganib potential as add-on therapy in Chronic Lymphocytic Leukemia (CLL) 2 , neuroblastoma 3 and Triple Negative Breast Cancer 4  therapy was reported  Discussions for further development of opaganib in neuroblastoma ongoing with Penn State University, Beat Childhood Cancer and Apogee, with potential for priority review voucher  RHB-102 (Bekinda®) being advanced as a late-stage potential therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects (e.g.

New preclinical data, independently presented in two posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, show positive effects of opaganib [1] as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC) The positive NB data from studies undertaken by Penn State University's Jeremy Hengst and Apogee Biotechnology, and funded by the Beat Childhood Cancer Foundation and Four Diamonds, 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 ceremide production enhancing programmed cell death (apoptosis) in cancer cells [2]   A second poster from 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 [3] Opaganib, a novel, potentially broad acting, oral, small molecule drug with demonstrated safety & efficacy profiles [4] , is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications RALEIGH, N.C., and TEL-AVIV, Israel, April 22, 2026 /PRNewswire/ -- RedHill Biopharma Ltd.

The full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. (THI), a jointly controlled entity of RedHill and Cumberland has started and is now being rolled out to support accelerated market penetration and expanded reach Focused on unlocking the full market potential of Talicia, the #1 branded U.S. gastroenterologist-prescribed H. pylori therapy 1 , THI and Cumberland will manage the launch and ongoing joint commercialization activities H.

Redhill Biopharma Ltd (NASDAQ: RDHL) stock is trading lower on Tuesday, possibly on profit-taking after the stock rallied roughly 36% on Monday, as per data from Benzinga Pro.

RHB-102 1  is a proprietary, advanced clinical-stage, once-daily, bimodal extended-release, oral tablet formulation of 5-HT3 antagonist, ondansetron, targeting oncology support, acute gastroenteritis and gastritis, IBS-D and GLP-1/GIP-associated gastrointestinal (GI) side effects -- Largey de-risked, RHB-102 development is supported by published positive U.S. Phase 3 & 2 results in gastroenteritis/gastritis and diarrhea-predominant irritable bowel syndrome (IBS-D) respectively, a positive comparative PK clinical study as part of the oncology support (CINV/RINV) program 2 , plus decades of ondansetron clinical use (>22 million annual U.S. ER prescriptions3 ) -- RHB-102 is clinically aligned, if approved, to improve titration success and reduce the #1 cause of discontinuing diabetes & weight loss therapies like Mounjaro®/Zepbound® & Ozempic®/Wegovy® -- Development planned under the accelerated FDA 505(b)(2) route of RHB-102 (Bekinda®) as a once-daily oral therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects. Phase 2 Proof-of-Concept study designed, and intellectual property expanded -- >2% of Americans take GLP-1 receptor agonist drugs 4 but estimates suggest up to 50% discontinue within 3 months 5 , potentially costing an estimated $35 billion in lost market value by 20306 TEL-AVIV, Israel and RALEIGH, N.C.

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CLL) therapy, is emerging as a therapeutic challenge, with leukemic cells persisting over time, even with combination therapy 1 Studies show that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cancer cells and that SPHK2 inhibition may reduce T-cell-induced activation and proliferation of venetoclax-resistant CLL cancer cells and resensitize previously resistant CLL cells2,3 New in vivo study shows adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduces CLL cell (CD19⁺, CD5⁺) counts by 50% compared to controls and lowered CD3+, CD4+ and CD8+ T cell counts compared to controls with lowered PD1 expression (CD8+) 4 Data shows opaganib's venetoclax combination potential in CLL; builds on multiple preclinical studies demonstrating opaganib's therapeutic add-on potential in oncology; further clinical evaluation ongoing in a Phase 2 study of opaganib + darolutamide in advanced prostate cancer Opaganib has a safety and tolerability profile shown in more than 470 clinical trials / expanded access participants. It targets multiple oncology, virology, inflammation, diabetes and obesity indications, with several U.S. government partnerships, including BARDA funding, in place TEL-AVIV, Israel and RALEIGH, N.C.

TEL-AVIV, Israel and RALEIGH, N.C. , Dec. 1, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.