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. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
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.