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 leader focused on gastrointestinal and infectious disease therapies. This page provides investors and industry professionals with comprehensive updates on the company’s clinical developments, regulatory milestones, and strategic initiatives.
Access real-time announcements including FDA submissions, clinical trial results, and partnership agreements. Track progress across RedHill’s commercial products like Talicia for H. pylori and Aemcolo for travelers’ diarrhea, along with late-stage candidates such as opaganib in oncology and inflammatory diseases.
Our curated news collection enables informed decision-making by consolidating material events including earnings reports, intellectual property updates, and research collaborations. Content spans therapeutic area breakthroughs, management commentary, and market expansion activities.
Bookmark this page for streamlined access to verified RedHill Biopharma updates. Check regularly for developments impacting the company’s position in gastrointestinal therapeutics and pandemic preparedness research.
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 <$b>$35 billion potential market value impact by 2030.
RedHill (Nasdaq: RDHL) announced clinical and regulatory progress for RHB-102 (ondansetron) as a once-daily, bimodal extended‑release oral tablet targeting oncology support, gastroenteritis, IBS‑D and GLP‑1/GIP receptor agonist therapy–associated GI side effects.
The company highlights published positive U.S. Phase 3 GUARD gastroenteritis and positive Phase 2 IBS‑D results, a positive comparative PK study for oncology support, expansion of intellectual property, and a planned Phase 2 proof‑of‑concept study for GLP‑1 GI side effects to start as early as 2026 under an accelerated FDA 505(b)(2) pathway.
RedHill cites >22 million U.S. ER ondansetron prescriptions annually, >2% of Americans taking GLP‑1 drugs, and estimates up to 50% GLP‑1 discontinuation within 3 months with an associated <$b>$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.
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.
RedHill Biopharma (NASDAQ: RDHL) announced a New York Supreme Court summary judgment win against Kukbo Co. Ltd. that is now final and eligible for enforcement.
The Court awarded a total of more than $10.5 million to RedHill: a main judgment of approximately $8.6 million (now final) and legal fees and expenses of approximately $1.9 million (includes principal and accrued interest). A 9% annual statutory interest continues to accrue on both awards. The legal-fee award remains subject to appeal until March 13, 2026. RedHill also secured a Korean court attachment against Kukbo to help prevent disposal of assets before enforcement.
RedHill Biopharma (Nasdaq: RDHL) received a Nasdaq Staff Determination notification on October 16, 2025 that the company did not meet the minimum stockholders' equity requirement under Listing Rule 5550(b)(1) by the compliance date of October 13, 2025.
RedHill said it intends to request a hearing before the Nasdaq Listing Qualifications Panel and that, following a transaction with Cumberland Pharmaceuticals announced October 20, 2025, it believes its stockholders' equity now exceeds the $2.5 million minimum. Submission of a hearing request will stay any delisting or suspension action and RedHill remains listed pending the Panel decision. There is no assurance the Panel will grant an extension or rule in RedHill's favor.
Cumberland (Nasdaq: CPIX) announced a co-commercialization joint venture with RedHill (Nasdaq: RDHL) to jointly commercialize the FDA-approved H. pylori therapy Talicia effective Oct 20, 2025.
Key terms: Cumberland will invest $4.0M, assume U.S. distribution and record sales; Talicia net revenues were $8.0M in 2024; net revenues will be shared 50/50. Product protections include U.S. patents through 2042 and 8 years QIDP exclusivity. Broad coverage and retail access include ~70% commercial and 60% government coverage and stocking at 1,700 CVS pharmacies.
RedHill (NASDAQ: RDHL) announced a strategic partnership with Cumberland Pharmaceuticals (NASDAQ: CPIX) on Oct 20, 2025 in which Cumberland will invest $4.0 million for a 30% ownership stake and joint control of RedHill's Talicia business, with RedHill retaining 70%.
The companies agreed an equal-sharing U.S. co-commercialization deal for Talicia's net revenues, with Cumberland providing national sales, marketing and operational support. Talicia is patent protected through 2042 and holds eight years of U.S. QIDP exclusivity. The transaction also contributes to RedHill's belief that it has stockholders' equity above the $2.5 million Nasdaq continued-listing threshold as of the press release date.
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