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. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
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.
RedHill Biopharma (NASDAQ: RDHL) has secured a significant legal victory in its ongoing dispute with Kukbo Co. Ltd. The Incheon District Court in Korea has granted an asset freeze on Kukbo's assets, following RedHill's successful $8.25 million plus legal fees summary judgment win in the New York Supreme Court.
The judgment stems from Kukbo's failure to honor subscription and licensing agreements signed in October 2021 and March 2022. The total amount includes $1.75 million in accrued interest at 9%. While Kukbo filed a notice of appeal on December 4, 2024, they have until June 4, 2025, to perfect their appeal, subject to potential extension. The New York Supreme Court has dismissed all of Kukbo's counterclaims.