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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) announced two significant developments for its H. pylori treatment Talicia®. First, Humana's Part D Plan now covers Talicia, providing access to over 8 million additional Medicare beneficiaries without requiring prior therapeutic steps or authorization, effective January 1, 2025.
Additionally, new data published in The Journal of Clinical Pharmacology supports Talicia's FDA-approved label change to a more convenient three-times daily (TID) dosing schedule with meals. The study demonstrated pharmacokinetic equivalence between the new TID regimen and the previous every 8-hour (Q8H) dosing schedule.
Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists and is listed as a first-line treatment option in the updated American College of Gastroenterology Clinical Guideline.
RedHill Biopharma (Nasdaq: RDHL) announced positive results from new in vivo studies of opaganib for treating gastrointestinal acute radiation syndrome (GI-ARS). The studies were conducted under the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) contract and confirmed opaganib's protective activity.
The company is in discussions with the National Institute of Allergy and Infectious Diseases (NIAID) regarding the next development phase following the FDA's Animal Rule pathway. Opaganib, an oral small molecule with a five-year shelf-life, is being developed as a potential medical countermeasure for GI-ARS, for which there are currently no approved therapies.
RedHill Biopharma has been awarded approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. The amount consists of $6.5 million plus interest of approximately $1.5 million. The case involves Kukbo's failure to make agreed payments to RedHill under a Subscription Agreement from October 25, 2021, and an Exclusive License Agreement from March 14, 2022. The Court dismissed all of Kukbo's counterclaims. Kukbo retains the right to seek an appeal of the judgment.
RedHill Biopharma (Nasdaq: RDHL) has been selected to present its drug opaganib at the JPEO-CBRND's 'Host Directed Therapeutics Industry Day' on October 29-30, 2024, in Alexandria, VA. The selection was based on the drug's demonstrated capabilities in prophylaxis and treatment of exposure to viruses, bacteria, and toxins.
The JPEO-CBRND, which manages U.S. government investments in chemical, biological, radiological, and nuclear defense equipment and medical countermeasures, will host the presentation. Opaganib, a novel host-directed oral drug, is being developed for various applications including oncology, viral infections, inflammatory diseases, and chemical/nuclear protection, with multiple ongoing U.S. government collaborations.
RedHill Biopharma (Nasdaq: RDHL) has announced a collaboration with Duke University School of Medicine to develop opaganib as a potential countermeasure against phosgene inhalation injury. The research aims to advance opaganib into U.S. government-sponsored development under the FDA's Animal Rule pathway to approval.
Phosgene, a toxic chemical used in industrial processes, poses a significant risk to public safety. The EPA has identified 123 sites in the U.S. that could potentially expose millions to phosgene. Currently, there is no approved antidote for phosgene inhalation injury, which can cause severe respiratory damage.
Opaganib, RedHill's novel, host-directed drug, is being developed for various indications, including chemical and nuclear/radioprotection. The collaboration with Duke University aims to determine if opaganib can provide protection against phosgene-induced damage and potentially be stockpiled for emergency use.
RedHill Biopharma has secured U.S. government funding through BARDA to advance opaganib for Ebola treatment. The funding will support the development of opaganib as a medical countermeasure (MCM) for Ebola virus disease (EBOV). Recent U.S. Army-funded studies showed that opaganib significantly increased survival in an EBOV model. Opaganib is a novel, potentially broad-acting drug with mutation-resistant antiviral and anti-inflammatory activity.
The development comes as there is an urgent need for effective and usable therapies for EBOV, which has a fatality rate of around 50% according to WHO. Opaganib represents an alternative host-directed therapeutic strategy for biodefense and global health preparedness. The drug is also being developed for other indications, including COVID-19, ARDS, and radiological and chemical protection.
RedHill Biopharma (Nasdaq: RDHL) has renewed its contract with Medi-Cal, California's Medicaid healthcare program, to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List with no prior authorization and a $0 copay. This renewal, effective October 1, 2024, benefits approximately 15 million Californian Medi-Cal patients.
The agreement follows the new American College of Gastroenterology (ACG) Clinical Guideline for H. pylori infection, which lists Talicia as an empirically prescribed first-line option. Talicia's all-in-one three-times daily formulation offers a simplified patient experience, supporting high rates of H. pylori eradication without requiring prior resistance testing. It remains the most prescribed branded H. pylori therapy by U.S. gastroenterologists.
RedHill Biopharma (Nasdaq: RDHL) has announced the issuance of a new U.S. patent for opaganib, valid through 2041. The patent covers the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib efficacy in treating COVID-19.
Post-hoc data from opaganib's Phase 2/3 study showed that patients with ≤60% FiO2 levels had better outcomes after 14 days of treatment compared to placebo, including:
- Increased number of patients no longer requiring supplemental oxygen (76.9% vs. 63.4%; p-value=0.033)
- 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; p-value=0.012)
- 62% reduction in mortality by day 42 (5.98% vs. 16.7%; p-value=0.019)
Opaganib is being developed for various indications, including oncology, viral infections, inflammatory diseases, and nuclear/radioprotection.
RedHill Biopharma (Nasdaq: RDHL) announced that its product Talicia® has been listed as a first-line choice for treating H. pylori infection in the new American College of Gastroenterology (ACG) Clinical Guideline. This is significant as it's the first update since Talicia's approval. Talicia offers a convenient all-in-one formulation taken three times daily, supporting high eradication rates without prior resistance testing.
Talicia is currently the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori, which affects about 35% of U.S. adults. Globally, H. pylori infects around 66% of the population and is classified as a Group 1 carcinogen by the WHO, being the strongest known risk factor for gastric cancer.
RedHill Biopharma (Nasdaq: RDHL) has successfully regained compliance with Nasdaq's minimum bid price requirement. The company received confirmation from the Nasdaq Listings Qualifications Department that it has met the necessary criteria for continued listing on The Nasdaq Capital Market. To achieve compliance, RedHill was required to maintain a minimum closing bid price of $1.00 per share for its American Depositary Shares (ADSs) for at least 10 consecutive business days. This milestone was reached on September 3, 2024, ensuring RedHill's continued presence on the Nasdaq exchange.
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