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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 (Nasdaq: RDHL) has announced positive preliminary results of a preclinical study indicating that opaganib effectively inhibits the replication of the COVID-19 Delta variant while preserving cell viability. Conducted with the University of Louisville, the study confirms opaganib's potential against multiple SARS-CoV-2 variants, highlighting its dual antiviral and anti-inflammatory properties. With ongoing Phase 2/3 trials, the company anticipates upcoming results that may bolster its position in the COVID-19 treatment landscape.
RedHill Biopharma announced two new U.S. patents, one for Opaganib targeting Ebola virus disease, providing protection until 2035, and another for RHB-104 for Crohn's disease, valid through 2029. The 475-patient Phase 2/3 study of Opaganib for severe COVID-19 is nearing completion, with top-line results imminent. Additionally, RHB-104's positive Phase 3 outcomes encourage further exploration towards its approval. RedHill is focusing on developing treatments for multiple indications including oncology and inflammatory diseases.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the issuance of two new patents by the U.S. Patent and Trademark Office. The first patent covers opaganib for treating Ebola virus disease, providing protection until 2035, while the second covers RHB-104 for bacterial infections, protected through 2029. Opaganib's development includes a Phase 2/3 study for COVID-19 treatment, with top-line results expected soon. The company is also exploring RHB-104's approval pathway following successful trial results for Crohn's disease.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its second quarter 2021 financial results on August 26, 2021. A live webcast will commence at 8:30 a.m. EDT, featuring operational highlights. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs such as Movantik, Talicia, and Aemcolo. Key clinical developments include ongoing studies for therapies targeting pulmonary NTM disease and COVID-19. The company emphasizes the importance of its upcoming announcements, which could impact investor sentiment.
RedHill Biopharma has announced a settlement with Apotex regarding patent litigation over Movantik (naloxegol). The agreement prevents Apotex from selling a generic version in the U.S. until October 1, 2030, unless earlier conditions are met. RedHill acquired Movantik's global rights from AstraZeneca in April 2020. This settlement concludes litigation with Apotex but does not end ongoing actions against other ANDA filers. The agreement will be submitted for regulatory review by the FTC and DOJ.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a settlement agreement with Apotex resolving patent litigation related to the generic version of Movantik® (naloxegol). Under the agreement, Apotex is prohibited from marketing a generic version in the U.S. until October 1, 2030, pending FDA approval. This settlement follows RedHill's acquisition of Movantik rights from AstraZeneca in April 2020. The litigation against another ANDA filer remains ongoing. The settlement will be submitted for review to the U.S. Federal Trade Commission and the Department of Justice.
RedHill Biopharma announced that OptumRx has added Talicia® to its unrestricted Commercial Formulary, enhancing access for over 8 out of 10 covered U.S. Commercial lives.
Talicia® is the first FDA-approved rifabutin-based therapy for H. pylori infection, a major risk factor for gastric cancer, affecting approximately 35% of the U.S. population. This strategic partnership with OptumRx represents a significant advancement in patient access to Talicia® amidst the growing resistance of H. pylori to standard treatments.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that OptumRx has added Talicia (omeprazole magnesium, amoxicillin, and rifabutin) to its unrestricted Commercial Formulary for H. pylori treatment, effective July 1, 2021. This inclusion significantly enhances patient access to Talicia, covering over 80% of U.S. Commercial lives. Talicia, the only FDA-approved rifabutin-based therapy for H. pylori, addresses antibiotic resistance issues. The company maintains eight years of U.S. market exclusivity for Talicia under its Qualified Infectious Disease Product designation.
RedHill Biopharma has announced the completion of follow-up for its global Phase 2/3 study of oral opaganib in severe COVID-19 patients, with results expected soon. The study involved 475 patients and examined the drug's efficacy against variants like Beta and Gamma. Opaganib is a dual antiviral and anti-inflammatory drug, potentially effective against new variants. Independent safety reviews have been positive, and the company is in discussions with regulatory bodies for approval pathways.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the completion of treatment and follow-up for its 475-patient global Phase 2/3 study of opaganib (ABC294640) in hospitalized COVID-19 pneumonia patients. Top-line results are expected soon. Opaganib demonstrated strong in vitro activity against COVID-19 variants and has received positive Phase 2 efficacy data. The primary endpoint focuses on patients breathing room air without oxygen support by Day 14. The company is in discussions with regulatory bodies for approval pathways and potential partnerships.
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