Welcome to our dedicated page for Redhill Biopharm news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharm stock.
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company whose news flow centers on gastrointestinal diseases, infectious diseases and oncology. Company press releases furnished on Form 6-K highlight both commercial developments around its FDA-approved H. pylori therapy Talicia® and clinical and preclinical updates from its late-stage pipeline, including opaganib (ABC294640), RHB-102 (Bekinda®), RHB-204 and RHB-107 (upamostat).
Investors following RDHL news can expect regular updates on Talicia’s commercialization, such as U.S. co-commercialization with Cumberland Pharmaceuticals, ex-U.S. licensing deals in regions like the Middle East, and milestone and royalty payments from international launches. RedHill also issues news on Talicia’s clinical positioning, including its status as a first-line option in American College of Gastroenterology guidelines and its role as a low-dose rifabutin-based therapy designed to address H. pylori antibiotic resistance.
On the development side, RedHill’s news frequently covers pipeline data and regulatory plans. Examples include positive in vivo and clinical results for opaganib in oncology and viral indications, Phase 2 and Phase 3 outcomes for RHB-102 in gastroenteritis, gastritis and IBS-D, and plans for RHB-102 in GLP-1/GIP receptor agonist therapy-associated gastrointestinal side effects. Updates also describe RHB-107’s late-stage development in non-hospitalized symptomatic COVID-19 and RHB-204’s planned studies in Crohn’s disease and pulmonary nontuberculous mycobacteria disease.
RedHill’s news feed additionally reports on Nasdaq listing compliance matters, capital-raising activities, and legal proceedings, such as New York Supreme Court judgments and related enforcement steps in the Kukbo litigation. For readers tracking RDHL, this page aggregates these corporate, clinical, regulatory and legal announcements in one place, allowing a consolidated view of the company’s ongoing activities and disclosures.
RedHill (CPIX) reported in vitro data showing its next-generation oral candidate RHB-204 demonstrates MAP killing comparable to RHB-104, achieved in spot and phage assays and using lower doses of two active ingredients. A Phase 2 trial in MAP-positive Crohn's disease patients is planned, with non-dilutive funding sought and multiple regulatory designations and patent protection through 2041.
RedHill Biopharma (Nasdaq: RDHL) reported full-year 2025 results and operational highlights on April 27, 2026, citing strategic transactions, commercial progress for Talicia and focused R&D activity. Key items include a $4.0M Cumberland investment into Talicia Holdings, Talicia U.S. net revenues of ~$8.9M, ex-U.S. revenues of ~$1.9M, a RHB-102 licensing deal worth up to $60M in milestones, a final $10.5M New York Supreme Court judgment in RedHill's favor, year-end cash of $4.1M and positive equity of $4.3M.
RedHill (Nasdaq: RDHL) presented independent preclinical data at AACR 2026 showing that opaganib may enhance chemotherapy efficacy in high‑risk neuroblastoma and augment STING‑mediated anti‑tumor immunity in triple‑negative breast cancer (TNBC).
Penn State and Apogee data indicate opaganib destabilized n‑Myc and increased ceramide‑driven apoptosis with OXDOX; University of Kansas data show opaganib plus low‑dose diABZI potentiated STING effects in TNBC. Opaganib holds FDA Orphan and Rare Pediatric Disease designations for neuroblastoma.
H. pylori infections market (CPIX) is projected to expand from a USD 270 million market in 2025 at a 9.4% CAGR through 2036 across the 6MM. US holds ~85% of 2025 revenue and ~57 million diagnosed prevalent cases; emerging therapies such as rifasutenizol, linaprazan glurate, and tegoprazan are expected to reshape treatment paradigms with reported Phase III eradication rates >90% for some candidates.
Challenges include a limited pipeline, geographic regulatory gaps, rising antibiotic resistance, and adherence issues with high pill burdens.
RedHill (Nasdaq:RDHL) and Cumberland (Nasdaq:CPIX) have begun the full U.S. sales and operational launch of Talicia under Talicia Holdings Inc. (THI), a 70/30 RedHill/Cumberland joint operating entity. Cumberland made a $4 million strategic investment and the joint model launched after an October 2025 agreement.
Talicia is positioned as the #1 branded U.S. gastroenterologist-prescribed H. pylori therapy, is patent-protected through 2042, holds eight years of U.S. market exclusivity (QIDP), and targets an estimated 1.6 million U.S. patients treated annually.
RedHill (Nasdaq: RDHL) announced clinical and regulatory progress for RHB-102 (ondansetron) as a once-daily, bimodal extended‑release oral tablet targeting oncology support, gastroenteritis, IBS‑D and GLP‑1/GIP receptor agonist therapy–associated GI side effects.
The company highlights published positive U.S. Phase 3 GUARD gastroenteritis and positive Phase 2 IBS‑D results, a positive comparative PK study for oncology support, expansion of intellectual property, and a planned Phase 2 proof‑of‑concept study for GLP‑1 GI side effects to start as early as 2026 under an accelerated FDA 505(b)(2) pathway.
RedHill cites >22 million U.S. ER ondansetron prescriptions annually, >2% of Americans taking GLP‑1 drugs, and estimates up to 50% GLP‑1 discontinuation within 3 months with an associated $35 billion potential market value impact by 2030.
RedHill (Nasdaq: RDHL) announced clinical and regulatory progress for RHB-102 (ondansetron) as a once-daily, bimodal extended‑release oral tablet targeting oncology support, gastroenteritis, IBS‑D and GLP‑1/GIP receptor agonist therapy–associated GI side effects.
The company highlights published positive U.S. Phase 3 GUARD gastroenteritis and positive Phase 2 IBS‑D results, a positive comparative PK study for oncology support, expansion of intellectual property, and a planned Phase 2 proof‑of‑concept study for GLP‑1 GI side effects to start as early as 2026 under an accelerated FDA 505(b)(2) pathway.
RedHill cites >22 million U.S. ER ondansetron prescriptions annually, >2% of Americans taking GLP‑1 drugs, and estimates up to 50% GLP‑1 discontinuation within 3 months with an associated $35 billion potential market value impact by 2030.
RedHill Biopharma (NASDAQ: RDHL) announced positive in vivo data showing that adding opaganib (a SPHK2 inhibitor) to venetoclax reduced Chronic Lymphocytic Leukemia (CLL) cell counts (CD19+, CD5+) by 50% versus controls in a mouse study dated Dec. 15, 2025.
The study also reported reduced CD3+, CD4+, CD8+ T cell counts and lower PD1 expression (CD8+) versus controls. Opaganib has an established safety profile in >470 clinical trial/expanded access participants and is under clinical evaluation in a Phase 2 trial in combination with darolutamide for advanced prostate cancer.
RedHill Biopharma (NASDAQ: RDHL) announced positive in vivo data showing that adding opaganib (a SPHK2 inhibitor) to venetoclax reduced Chronic Lymphocytic Leukemia (CLL) cell counts (CD19+, CD5+) by 50% versus controls in a mouse study dated Dec. 15, 2025.
The study also reported reduced CD3+, CD4+, CD8+ T cell counts and lower PD1 expression (CD8+) versus controls. Opaganib has an established safety profile in >470 clinical trial/expanded access participants and is under clinical evaluation in a Phase 2 trial in combination with darolutamide for advanced prostate cancer.
RedHill Biopharma (NASDAQ: RDHL) announced it has regained compliance with Nasdaq's stockholders' equity requirement under Listing Rule 5550(b)(1). Nasdaq confirmed compliance on November 26, 2025, restoring the company's conformity with listing standards. The company cited ongoing 2025 strategic initiatives, including the Talicia partnership with Cumberland Pharmaceuticals, and continued focus on operational efficiency. RedHill was advised in the process by Donohoe Advisory.