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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 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.
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.
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