Welcome to our dedicated page for Redhill Biopharma Ltd. news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharma Ltd. stock.
RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company centered on gastrointestinal and infectious diseases. The company is headquartered in Israel and operates internationally, with teams in the U.S., Canada, and Europe. RedHill's primary focus is the development and commercialization of late-stage clinical therapeutics and patented reformulations of existing drugs.
Core Business and Products
RedHill's flagship commercial products in the U.S. include Talicia® (omeprazole, amoxicillin, and rifabutin) for treating Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® (rifamycin) for treating travelers' diarrhea. Talicia® is unique as the only FDA-approved rifabutin-containing therapy optimized for H. pylori eradication, addressing the rising concern of antibiotic resistance.
Key Development Programs
- Opaganib (ABC294640): A first-in-class oral SPHK2 inhibitor with applications in pandemic preparedness, oncology, and radioprotection. It is undergoing trials for multiple indications including Acute Radiation Syndrome (ARS) and COVID-19, and has shown promising results in pre-clinical studies against Ebola.
- RHB-107 (upamostat): An oral broad-acting, host-directed serine protease inhibitor targeting non-hospitalized symptomatic COVID-19, supported by U.S. Department of Defense funding in a 300-patient Phase 2 trial. It also shows potential for cancer and inflammatory gastrointestinal diseases.
- RHB-102: A novel therapy for chemotherapy and radiotherapy-induced nausea and vomiting, with positive Phase 3 results for acute gastroenteritis.
- RHB-104: Demonstrated efficacy in a Phase 3 study for Crohn's disease.
- RHB-204: In Phase 3 development for pulmonary nontuberculous mycobacteria (NTM) disease.
Recent Achievements
Recent publications highlight Opaganib's efficacy in enhancing long-term survival in radiation exposure models, and its selection by the U.S. NIH for the Radiation and Nuclear Countermeasures Program. Additionally, the company secured a new U.S. patent for Talicia®, extending its protection until 2034, and obtained a new Chinese patent for Opaganib in combination with immune checkpoint inhibitors, valid through 2040.
Financial Performance
For the year ending December 31, 2023, RedHill reported net revenues of $6.5 million, primarily from Talicia®, with a gross profit of $3.1 million. The company has reduced its liabilities significantly following the divestiture of Movantik, and its financial health is bolstered by ongoing U.S. government funding for key R&D programs.
Strategic Direction
RedHill is focused on leveraging its solid pipeline and partnerships to address unmet medical needs in gastrointestinal and infectious diseases. The company is strategically positioned to benefit from growing geopolitical and health threats, aiming to provide innovative solutions in challenging healthcare environments.
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.
RedHill Biopharma announced that its product Movantik (naloxegol) is now preferred and unrestricted on a major National Medicare Part D formulary, effective January 1, 2022. This inclusion expands Movantik's coverage, reaching over 10 million additional Americans and increasing total commercial coverage to 152 million. The drug is the leading treatment for opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
RedHill Biopharma (RDHL) reported its operational highlights and financial results for Q3 2021, achieving record net revenues of $21.6 million. The company saw a 15% increase in new prescriptions for Talicia and 1.1% for Movantik. The gross margin improved from 51% to 57%, and operating loss decreased to $17.4 million from $24.9 million. Notably, opaganib demonstrated a 62% reduction in mortality in a post-hoc analysis of COVID-19 patients. Cash balance stood at $51.5 million as of September 30, 2021, bolstered by strategic investments and a public offering.
FAQ
What is the current stock price of Redhill Biopharma Ltd. (RDHL)?
What is the market cap of Redhill Biopharma Ltd. (RDHL)?
What does RedHill Biopharma Ltd. specialize in?
What are RedHill's main commercial products?
What is Opaganib, and what are its potential uses?
What stage is RHB-107 currently in?
What recent achievements has RedHill Biopharma accomplished?
How is RedHill Biopharma's financial performance?
What is the strategic direction of RedHill Biopharma?
Who are RedHill Biopharma's development partners?
What is the significance of RedHill's new patents?