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 (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.
RedHill Biopharma (NASDAQ: RDHL) signed a licensing agreement to commercialize Talicia in new Middle East markets on Oct 6, 2025. The deal provides $500,000 guaranteed (including a $250,000 upfront payment and $250,000 fixed within 18 months), plus a minimum of $1.3 million in potential near-term milestone payments and tiered royalties up to mid‑teens% on Talicia net sales.
Talicia is described as the only FDA‑approved all‑in‑one, low‑dose rifabutin‑based H. pylori therapy, listed as a first‑line option in ACG guidelines, patent‑protected through 2042, and granted eight years of U.S. exclusivity under QIDP.
RedHill Biopharma (NASDAQ: RDHL) signed a licensing agreement to commercialize Talicia in new Middle East markets on Oct 6, 2025. The deal provides $500,000 guaranteed (including a $250,000 upfront payment and $250,000 fixed within 18 months), plus a minimum of $1.3 million in potential near-term milestone payments and tiered royalties up to mid‑teens% on Talicia net sales.
Talicia is described as the only FDA‑approved all‑in‑one, low‑dose rifabutin‑based H. pylori therapy, listed as a first‑line option in ACG guidelines, patent‑protected through 2042, and granted eight years of U.S. exclusivity under QIDP.
RedHill Biopharma (Nasdaq: RDHL) has secured a significant legal victory as the New York Supreme Court upheld its original summary judgment against Kukbo Co. Ltd. The court dismissed Kukbo's defense and confirmed RedHill's compliance with agreement obligations.
The total award amounts to approximately $10 million, consisting of an $8.25 million original award plus $1.82 million for legal costs and expenses, including 9% statutory interest. Additionally, RedHill obtained an asset attachment order from Korea's Incheon District Court, preventing Kukbo from disposing of assets before judgment enforcement.
RedHill Biopharma (Nasdaq: RDHL) has secured a significant legal victory as the New York Supreme Court upheld its original summary judgment against Kukbo Co. Ltd. The court dismissed Kukbo's defense and confirmed RedHill's compliance with agreement obligations.
The total award amounts to approximately $10 million, consisting of an $8.25 million original award plus $1.82 million for legal costs and expenses, including 9% statutory interest. Additionally, RedHill obtained an asset attachment order from Korea's Incheon District Court, preventing Kukbo from disposing of assets before judgment enforcement.
RedHill Biopharma (NASDAQ:RDHL) reported its H1 2025 financial results, showing significant operational improvements. Net revenues increased 59% to $4.1 million compared to H1 2024, with Talicia net revenues reaching $3.8 million. The company achieved a doubled gross profit and reduced operating loss to $4.4 million from $8.4 million year-over-year.
Key developments include the initiation of a Bayer-supported Phase 2 study for opaganib in prostate cancer, positive FDA feedback for RHB-204 in Crohn's disease, and an up to $60 million global licensing deal with Hyloris Pharmaceuticals for RHB-102. The company secured additional Talicia formulary coverage for 8 million more lives, reaching over 204 million covered lives total.
Financial stability was enhanced with $13.5 million available through ATM and Market Purchase agreements, while maintaining a cash balance of $3 million as of June 30, 2025.
RedHill Biopharma (NASDAQ:RDHL) has secured an additional $1.82 million award for legal costs and expenses from the New York Supreme Court, supplementing its previous $8.25 million summary judgment victory against Kukbo Co. Ltd. Both awards include a 9% ongoing statutory interest accrual.
The company has also obtained an attachment grant from Korea's Incheon District Court against Kukbo, enabling court-ordered seizure of Kukbo's assets to prevent disposal before judgment enforcement. While Kukbo has appealed the summary judgment decision, with oral arguments scheduled for September, they retain the right to appeal the latest legal costs award.
RedHill Biopharma (NASDAQ:RDHL) has received its first ex-U.S. sales milestone payment, royalties, and other payments for Talicia, totaling $1.1 million. Talicia, the first FDA-approved rifabutin-based therapy for H. pylori infection, is currently the leading branded first-line treatment prescribed by U.S. gastroenterologists.
The drug maintains strong market protection through FDA's QIDP designation, providing 8 years of market exclusivity, with patent protection extending through 2042. Clinical data shows Talicia achieved up to 90% eradication rate in adherent patients, significantly outperforming traditional clarithromycin-based therapies which showed only 68.5% effectiveness, dropping to 32% in resistant cases.
RedHill Biopharma (NASDAQ:RDHL) has received positive FDA feedback for its groundbreaking RHB-204 Crohn's disease treatment program. The FDA guidance enables a novel Phase 2 study targeting Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease patients - the first of its kind.
RHB-204, patent-protected until 2041, is an optimized formulation of RHB-104, which demonstrated 64% improved efficacy in Phase 3 trials. The drug features a 40% reduced pill burden and enhanced tolerability. The company has established collaborations with academic centers for advanced MAP detection diagnostics, addressing a previous major development barrier.
The Crohn's disease market is projected to grow from $13.6 billion in 2024 to over $19 billion by 2033. The company expects non-dilutive funding for the program and anticipates benefits including pediatric orphan drug designation transfer and potential breakthrough therapy status.
RedHill Biopharma (NASDAQ: RDHL) has initiated patient recruitment for a Phase 2 study evaluating opaganib in combination with darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The study, sponsored by ANZUP and supported by Bayer and Ramsay Hospital Research Foundation, will be conducted across 10 sites in Australia and New Zealand.
The 60-participant placebo-controlled randomized study will utilize the PCPro™ lipid biomarker test to identify poor-prognosis patients who may benefit from the combination therapy. The study's primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Professor Lisa Horvath from Sydney's Chris O'Brien Lifehouse will lead the research.
The study aims to address prostate cancer, which is the second most diagnosed cancer globally with approximately 1.5 million new cases and 400,000 deaths annually. The global prostate cancer market is valued at approximately $12 billion.
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