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 Ltd. (Nasdaq: RDHL) has signed an exclusive license agreement with Gaelan Medical for Talicia®, an H. pylori therapy, in the UAE. Under the deal, RedHill will receive an upfront payment of $2 million and may earn milestone payments and royalties on sales. Gaelan Medical will exclusively commercialize Talicia in the UAE and has a right of first refusal for the Gulf region. The agreement comes amid rising H. pylori infection rates in the UAE, affecting 41% of the population, highlighting the need for effective treatment options.
RedHill Biopharma Ltd. (NASDAQ:RDHL) announced that its board members and management, including CEO Dror Ben-Asher, purchased approximately 66,000 American Depositary Shares (ADSs) since mid-October 2021 in open-market transactions. The company focuses on gastrointestinal and infectious diseases and promotes drugs like Movantik, Talicia, and Aemcolo. Key clinical programs include RHB-204 for pulmonary NTM disease and opaganib for COVID-19. The press release includes forward-looking statements, indicating potential uncertainties in their clinical trial progress and commercial success.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that its board members and senior management, including Chairman & CEO Dror Ben-Asher, purchased approximately 66,000 American Depositary Shares in open-market transactions since mid-October. The company focuses on gastrointestinal and infectious diseases, promoting drugs like Movantik, Talicia, and Aemcolo. Key clinical programs include RHB-204 for pulmonary NTM disease and opaganib for COVID-19 and various cancers. These insider purchases may signal confidence in the company's future performance.
RedHill Biopharma has revealed alarming rates of clarithromycin prescribing for H. pylori treatment in a recent study published in Digestive Diseases and Sciences. The research shows that over 80% of H. pylori prescriptions are clarithromycin-based, despite rising antibiotic resistance and a failure rate of nearly 40% in treatment-naive patients. The study emphasizes the effectiveness of Talicia, an FDA-approved therapy without clarithromycin, achieving approximately 89% eradication rates. The findings bring attention to the urgent need for changes in treatment practices.
RedHill Biopharma (RDHL) announced a study published in Digestive Diseases and Sciences revealing troubling rates of physician prescriptions for clarithromycin-based treatments for H. pylori infections. Over 80% of prescriptions were clarithromycin-based, showing only a 60% eradication rate. In contrast, RedHill's Talicia, a clarithromycin-free treatment, offered eradication rates of approximately 89-90% in clinical trials. The study highlights urgent changes needed in prescribing habits due to rising antibiotic resistance.
RedHill Biopharma announced that its drug Opaganib operates through a unique mechanism, targeting human host cells rather than the virus, making it likely effective against Omicron and other variants. Regulatory submissions for Opaganib are in progress, with initial feedback expected from the U.S. FDA in January 2022 and from the European Medicines Agency by the end of 2021. Furthermore, RHB-107, another COVID-19 treatment, is awaiting top-line data early next year. Positive clinical data suggest Opaganib could significantly reduce mortality in moderately severe COVID-19 patients.
RedHill Biopharma (Nasdaq: RDHL) announced that its drug Opaganib targets human host cells, making it effective against COVID-19 variants like Omicron. The company has submitted global Phase 2/3 data to the EMA, FDA, and UK MHRA, with feedback expected soon. Opaganib may significantly benefit hospitalized patients with advanced disease, as treatment starts later than conventional options like Pfizer and Merck. The company is also advancing RHB-107, another antiviral targeting COVID-19, with top-line data anticipated in Q1 2022.
RedHill Biopharma has published new data in the journal GastroHep showing that its drug Talicia achieves high eradication rates for H. pylori infection, irrespective of patient BMI. In a post-hoc analysis of 269 patients, eradication rates reached 88.1% for patients with BMI >30 kg/m² and 90.9% for those with BMI >40 kg/m², compared to active comparators at 62.9% and 31.8% respectively. Talicia is FDA approved as a first-line therapy, offering a promising option for treating H. pylori in overweight and obese populations.
RedHill Biopharma (Nasdaq: RDHL) announced a study published in GastroHep showing that Talicia® effectively eradicates Helicobacter pylori across all body mass index (BMI) groups, including obese patients. The study analyzed data from 269 patients in Phase 3 trials and found eradication rates of approximately 90% for those with BMI over 30 kg/m², significantly outperforming active comparators. Talicia's low resistance rate compared to clarithromycin further underscores its potential as a first-line therapy, especially as obesity is a major risk factor for treatment failure.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that Movantik® (naloxegol) has been approved as a preferred and unrestricted brand on a major National Medicare Part D formulary, effective January 1, 2022. This inclusion allows over 10 million Americans access to Movantik for treating opioid-induced constipation. With this approval, Movantik now achieves coverage of 90% of U.S. commercial lives and over 94% of Medicare Part D lives. The company emphasizes the importance of managing constipation associated with opioid use for effective chronic pain management.