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) announced that its board of directors and senior management purchased approximately 180,000 American Depositary Shares (ADSs) in open-market transactions from mid-September to October 15, 2021. This significant insider buying highlights the confidence that executives have in the company’s future. RedHill focuses on treatments for gastrointestinal and infectious diseases, with leading products like Movantik and Talicia. The company is also advancing several clinical programs targeting serious health issues.
RedHill Biopharma announced the granting of U.S. Patent No. 11,135,172 covering Talicia, its medicine for treating H. pylori infections, valid through 2034. This patent is the fifth listed in the FDA Orange Book for Talicia, which aims to combat the increasing resistance of H. pylori to traditional therapies. Talicia is an all-in-one capsule containing a proton pump inhibitor and two antibiotics, showing an 84% eradication rate in pivotal studies. H. pylori affects approximately 35% of the U.S. population, presenting a significant health risk.
RedHill Biopharma (Nasdaq: RDHL) announced the granting of U.S. Patent No. 11,135,172, which reinforces protection for Talicia, its FDA-approved treatment for H. pylori infection, extending patent life through 2034. This patent is part of an effort to bolster an international patent portfolio addressing antibiotic resistance concerns. Talicia, a fixed-dose capsule combining antibiotics and a proton pump inhibitor, showed an 84% eradication rate in pivotal studies. The company aims to list this patent in the FDA's Orange Book, enhancing Talicia's market exclusivity.
RedHill Biopharma announced that its drug Talicia® has been added to the Medi-Cal Contract Drug List without prior authorization requirements, effective October 1, 2021. This addition provides coverage for approximately two million patients in California, enhancing accessibility for H. pylori treatment. Talicia is the only FDA-approved rifabutin-based therapy for H. pylori infections, addressing the resistance seen with standard therapies. The drug offers an impressive 84% eradication rate in clinical trials, with strong market exclusivity until 2034.
RedHill Biopharma (Nasdaq: RDHL) announced that Medi-Cal, California's Medicaid program, added its drug Talicia® (omeprazole magnesium, amoxicillin, and rifabutin) to its Contract Drug List effective October 1, 2021. This change allows for easier access for approximately two million patients as no prior authorization is required for treatment of H. pylori infections. Talicia® is significant due to its effectiveness against antibiotic-resistant strains and has shown an 84% eradication rate in clinical trials. The drug holds U.S. market exclusivity until 2027 under its Qualified Infectious Disease Product designation.
RedHill Biopharma (Nasdaq: RDHL) reported positive findings from a Phase 2/3 study of its oral drug opaganib in hospitalized COVID-19 patients. The analysis showed a 62% reduction in mortality among those treated compared to the placebo group. Key outcomes included 77% of opaganib patients reaching room air by Day 14 and a median discharge time of 10 days versus 14 days for placebo, suggesting significant clinical benefits. The company plans to discuss these results with regulators to determine future steps for opaganib as a potential treatment for severe COVID-19.
RedHill Biopharma (Nasdaq: RDHL) announced a settlement and license agreement with Aurobindo Pharma regarding the patent litigation for Movantik® (naloxegol). The agreement prevents Aurobindo from selling a generic version in the U.S. until April 1, 2031, pending FDA approval. RedHill acquired global rights to Movantik from AstraZeneca in April 2020, excluding Europe and Canada. The settlement concludes all ongoing Hatch-Waxman patent litigations against ANDA filers prior to patent expiration.
RedHill Biopharma (Nasdaq: RDHL) has announced preliminary top-line data from its 475-patient Phase 2/3 study of opaganib in hospitalized patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint, though trends indicated potential benefits of opaganib compared to placebo. Safety data showed good tolerability with a balance of adverse events. The findings suggest exploring opaganib's use in earlier disease stages. The company plans further discussions with regulators regarding next steps and ongoing studies.
RedHill Biopharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for a Phase 2/3 study of RHB-107 (upamostat), aimed at treating non-hospitalized symptomatic COVID-19 patients. This approval comes as the U.S. study expands its site locations to enhance patient recruitment. RHB-107, an oral antiviral targeting serine proteases, shows promise against emerging viral variants with prior studies demonstrating clinical safety. Concurrently, opaganib is being evaluated in a global Phase 2/3 trial for severe COVID-19.
RedHill Biopharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Phase 2/3 study of RHB-107 (upamostat), an oral treatment for symptomatic COVID-19 patients not requiring hospitalization. The study aims to assess the safety and efficacy of RHB-107, with expanded U.S. sites to boost patient recruitment. RHB-107 targets viral entry through human cell factors and shows promise against emerging variants. Concurrently, the company is awaiting top-line results from its opaganib study for severe COVID-19 cases.
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