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.
Company Overview
RedHill Biopharma Ltd (NASDAQ: RDHL) is a specialty biopharmaceutical company dedicated to the development and commercialization of innovative therapies for gastrointestinal, infectious, and oncological diseases. With a focus on late clinical-stage development and patented drug formulations, the company leverages extensive expertise in clinical research, regulatory strategy, and commercial operations to address unmet medical needs.
Core Business and Market Position
RedHill Biopharma excels in advancing therapeutic candidates from concept to market. Its dual approach of improving existing drugs and pioneering new therapeutic candidates has established a robust pipeline. The company’s flagship products include Talicia, a novel treatment for Helicobacter pylori infections, and Aemcolo, targeted for travelers' diarrhea. Alongside these commercially marketed drugs, RedHill is actively advancing a number of clinical-stage programs such as opaganib, a first‐in‐class, orally administered sphingosine kinase-2 selective inhibitor, and several other candidates (RHB-107, RHB-102, RHB-104, RHB-204) aimed at addressing critical indications in oncology, viral infections, radiation protection, and inflammatory diseases.
Research and Development Excellence
Emphasizing rigorous research and robust clinical validation, RedHill’s R&D strategy leverages both internal expertise and strategic collaborations with U.S. government agencies and leading academic institutions. The company’s clinical trials and research programs are designed to meet the rigorous standards expected in the biopharmaceutical industry, enhancing its credibility and establishing its authority in the field. Through its focus on clinical efficacy, safety, and patented drug formulations, RedHill reinforces its commitment to innovative therapies and patient outcomes.
Operational Strengths and Competitive Differentiators
A key strength of RedHill is its experienced management team, which includes seasoned professionals from Israel, the U.S., Canada, and Europe. Their combined expertise in regulatory affairs, commercialization, and transactional experience allows the company to execute cost-efficient strategies while positioning its products favorably in a competitive market. This balanced approach not only strengthens its current market offering but also ensures continuous innovation and resilience in the face of industry challenges.
Investor and Market Relevance
For investors and market analysts, RedHill Biopharma represents a compelling blend of commercial successes and forward-looking clinical development programs. The company’s strategic focus on gastrointestinal and infectious therapies, combined with its robust pipeline and global network of expertise, underscores its value as a differentiated player in the specialty biopharmaceutical sector. Through its comprehensive approach to product development and commercialization, RedHill continues to solidify its position within a competitive and evolving market landscape.
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.
RedHill Biopharma (Nasdaq: RDHL) announced that Movantik® (naloxegol) has been added as an unrestricted preferred brand to a major national commercial formulary, effective July 1, 2021. This inclusion means over 30 million more Americans will gain access to Movantik, which treats opioid-induced constipation. Nearly 90% of U.S. commercial lives are now covered. Movantik's effectiveness and importance for pain management are emphasized, with ongoing efforts to expand formularies further. The safety information highlights potential gastrointestinal risks associated with Movantik usage.
RedHill Biopharma (Nasdaq: RDHL) announced preliminary results from a preclinical study showing that opaganib effectively inhibits the Beta and Gamma COVID-19 variants. This investigational oral drug targets sphingosine kinase-2 (SK2), crucial for viral replication. The global Phase 2/3 study of opaganib, fully enrolled with 475 patients, is nearing completion, with encouraging preliminary safety and efficacy data. Opaganib's dual mechanism combines antiviral and anti-inflammatory effects, showing potential against emerging COVID-19 variants.
RedHill Biopharma (RDHL) announced positive Phase 2 data for oral opaganib (Yeliva®) in hospitalized COVID-19 patients at the World Microbe Forum. In a 40-patient study, 50% of opaganib recipients reached room air by Day 14, compared to 22% for placebo. Additionally, 86.4% of opaganib patients were discharged by Day 14 versus 55.6% for placebo. Median discharge time was 6 days for opaganib versus 7.5 days for placebo. No significant safety issues were noted. Following the completion of a 475-patient global Phase 2/3 study, further data is expected soon.
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