Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma Ltd. (Nasdaq: RDHL) reported strong sales growth in Q4 2021, driven by enhancements in its salesforce and cost control measures. The company is positioned to achieve commercial profitability in 2022, alongside advancing its late-stage pipeline, particularly with the orally-administered opaganib for COVID-19. Preliminary financial data indicates a potential record quarterly revenue, though it remains subject to year-end audit adjustments. Regulatory discussions are ongoing for opaganib's approval.

On February 7, 2022, RedHill Biopharma (NASDAQ: RDHL) announced significant findings from the Phase 2/3 study of its oral drug opaganib for severe COVID-19 patients. The analysis revealed a remarkable 70.2% reduction in mortality for patients receiving opaganib alongside remdesivir and corticosteroids, with a mortality rate of 6.98% compared to 23.4% for placebo (p-value=0.034). Additionally, opaganib showed a 34% improvement in recovery time (p-value=0.013). Regulatory discussions are ongoing, with potential emergency applications planned in several countries in the first half of 2022.

RedHill Biopharma (Nasdaq: RDHL) reported a prespecified analysis from its Phase 2/3 study of oral opaganib, showing a significant improvement in median viral RNA clearance in severely ill COVID-19 patients. Opaganib achieved a median clearance time of 10 days compared to a placebo, which did not reach median clearance by 14 days, indicating a hazard ratio of 1.34 (p-value 0.043). Additionally, opaganib demonstrated a 62% reduction in mortality in a post-hoc analysis. As RedHill discusses regulatory approval pathways, these results underline opaganib's potential as an antiviral treatment.

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.