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.
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company whose news flow centers on gastrointestinal diseases, infectious diseases and oncology. Company press releases furnished on Form 6-K highlight both commercial developments around its FDA-approved H. pylori therapy Talicia® and clinical and preclinical updates from its late-stage pipeline, including opaganib (ABC294640), RHB-102 (Bekinda®), RHB-204 and RHB-107 (upamostat).
Investors following RDHL news can expect regular updates on Talicia’s commercialization, such as U.S. co-commercialization with Cumberland Pharmaceuticals, ex-U.S. licensing deals in regions like the Middle East, and milestone and royalty payments from international launches. RedHill also issues news on Talicia’s clinical positioning, including its status as a first-line option in American College of Gastroenterology guidelines and its role as a low-dose rifabutin-based therapy designed to address H. pylori antibiotic resistance.
On the development side, RedHill’s news frequently covers pipeline data and regulatory plans. Examples include positive in vivo and clinical results for opaganib in oncology and viral indications, Phase 2 and Phase 3 outcomes for RHB-102 in gastroenteritis, gastritis and IBS-D, and plans for RHB-102 in GLP-1/GIP receptor agonist therapy-associated gastrointestinal side effects. Updates also describe RHB-107’s late-stage development in non-hospitalized symptomatic COVID-19 and RHB-204’s planned studies in Crohn’s disease and pulmonary nontuberculous mycobacteria disease.
RedHill’s news feed additionally reports on Nasdaq listing compliance matters, capital-raising activities, and legal proceedings, such as New York Supreme Court judgments and related enforcement steps in the Kukbo litigation. For readers tracking RDHL, this page aggregates these corporate, clinical, regulatory and legal announcements in one place, allowing a consolidated view of the company’s ongoing activities and disclosures.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has entered a strategic agreement with South Korea's Kukbo Co. Ltd. for a $10 million private placement, sold in two tranches. The first tranche of $5 million has been completed, issuing 827,586 American Depositary Shares (ADSs) at $6.04 each, a 20% premium. Kukbo will have a six-month option for licensing RedHill's late-stage clinical assets in select Asian territories. This investment aims to support the advancement of RedHill's COVID-19 therapeutic, opaganib, among others.
RedHill Biopharma (NASDAQ:RDHL) recently presented new analyses of Talicia® and Movantik® at the ACG 2021 Annual Scientific Meeting. The findings support Talicia's recommendation as a first-line therapy for H. pylori eradication due to low resistance rates. Talicia's studies indicate that unique dosing achieves high eradication rates. Movantik demonstrated rapid symptom relief for extreme opioid-induced constipation in pivotal trials, with a favorable safety profile. Both products address significant healthcare challenges, with Talicia highlighting the clinical detriments of clarithromycin use.
RedHill Biopharma (Nasdaq: RDHL) has presented new data analyses for Talicia and Movantik at the ACG 2021 Annual Scientific Meeting.
The Talicia analyses highlight the high utilization of clarithromycin despite resistance issues and suggest that Talicia's dosing leads to effective H. pylori eradication. The Movantik data demonstrate its efficacy in providing rapid relief from severe opioid-induced constipation.
These studies reinforce the competitive positioning of Talicia and Movantik in the market, addressing significant public health concerns.
RedHill Biopharma Ltd. (Nasdaq: RDHL) plans to present a corporate overview at the BIO-Europe Digital Conference from October 25-28, 2021. Mr. Adi Frish, Chief Corporate & Business Development Officer, will lead the presentation. It will be available on-demand for 30 days on the company’s website. RedHill focuses on gastrointestinal and infectious diseases, with key products including Movantik®, Talicia®, and Aemcolo®. The company is advancing several late-stage clinical programs for conditions such as COVID-19 and Crohn's disease.
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.
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