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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 that the National Institutes of Health's Radiation and Nuclear Countermeasures Program has selected opaganib for testing as a potential treatment for Acute Radiation Syndrome (ARS). This collaboration aims to validate opaganib's efficacy in pre-clinical animal models under the RNCP contract. Following recent FDA guidance on the Animal Rule for opaganib, the company expects the collaboration to enhance its development program, potentially leading to FDA approval for use in radiological emergencies. Opaganib is an oral pill with a five-year shelf-life, designed for easy administration during such incidents.
RedHill Biopharma has announced a positive outcome from its pre-Marketing Authorisation Application (MAA) meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for its drug RHB-102 (BEKINDA). The drug aims to manage nausea and vomiting induced by chemotherapy and radiotherapy (CINV/RINV). The MAA submission is expected in the second half of 2023. If approved, RHB-102 could be the first oral 24-hour extended-release 5-HT3 antiemetic in the UK, addressing a significant market need, given that 70-80% of patients undergoing chemotherapy experience these symptoms. The global market for CINV/RINV is projected to exceed $10 billion by 2031.
RedHill Biopharma announced that the UK MHRA has given a positive opinion on RHB-102 (Bekinda) for treatment of chemotherapy and radiotherapy-induced nausea and vomiting (CINV/RINV). This feedback supports the planned submission of a UK Marketing Authorisation Application in the second half of 2023. If approved, RHB-102 could be the first oral 24-hour extended-release 5-HT3 antiemetic drug in the UK for CINV/RINV. The global market for CINV/RINV treatments is projected to exceed $10 billion by 2031, with significant growth expected in the UK.
RedHill Biopharma (Nasdaq: RDHL) announced a positive outcome from a scheduled Type B meeting with the FDA, receiving guidance on the regulatory pathway for its investigational drug opaganib to treat Acute Radiation Syndrome (ARS). The FDA's Animal Rule allows the use of animal studies in place of human trials when ethical concerns arise. Opaganib, a small molecule with a five-year shelf life, could be stockpiled by governments for emergency situations. Collaboration with U.S. agencies is planned for further development. A recent study highlighted opaganib's potential against radiation toxicity, supporting its role in homeland security.
RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that it has extinguished all debt obligations under its Credit Agreement with HCR, transferring rights to Movantik® in exchange. This strategic decision allows RedHill to become debt-free, freeing cash flow previously used for debt servicing. HCR will take on post-closing liabilities while RedHill retains pre-closing liabilities concerning Movantik. RedHill will provide transition services to HCR for up to 12 months, generating revenue during this period. The company aims to replace Movantik revenues with new products and maximize the potential of its existing drug portfolio.
RedHill Biopharma has received a Notice of Allowance from the USPTO for a patent covering RHB-204, a promising treatment for Non-tuberculosis Mycobacteria (NTM) disease. This patent is expected to extend protection until 2041. RHB-204 is currently in a Phase 3 study in the U.S. as the first stand-alone standard of care for NTM disease caused by MAC infection. It has received multiple FDA designations, including Fast Track and Orphan Drug status, ensuring market exclusivity for up to 12 years in the U.S. Discussions with potential partners for RHB-204 are ongoing, highlighting its commercial potential in addressing a growing public health concern.
DUBLIN, Jan. 19, 2023 /PRNewswire/ -- ResearchAndMarkets.com has added a new report titled "Antibiotic Resistance Markets - Therapeutics by Pathogen and Therapy Type". This report identifies key opportunities in the growing field of antimicrobial resistance, highlighting new technologies and drugs in development. It covers over 100 biotechnology companies and provides five-year market forecasts. Key topics include strategic analysis, the role of diagnostics, and a dynamic overview of market players, alongside insights into therapeutic technology development opportunities. The report aims to empower informed investment decisions based on the latest data.
The immune thrombocytopenia market is projected to grow significantly due to increasing disease prevalence and promising therapies in development, with a market size of approximately USD 3,100 million in the 7MM in 2021. The estimated prevalent cases in the 7MM reached 184K in 2021. Key companies like Sanofi and UCB Biopharma are advancing novel treatments, including Rilzabrutinib and Efgartigimod. While the market is expected to expand with new product launches, it faces challenges from alternative treatments and declining pediatric treatment rates. The market’s compound annual growth rate (CAGR) is forecasted at 5.4% until 2032.
RedHill Biopharma (Nasdaq: RDHL) announced positive results from a U.S. Phase 2 study of RHB-107 (upamostat) for non-hospitalized symptomatic COVID-19, published in the International Journal of Infectious Diseases. The study achieved its primary endpoint of safety and tolerability, showing a 100% reduction in hospitalization (0/41 on RHB-107 vs. 15% on placebo) and faster recovery (median of 3 days vs. 8 days). RHB-107 is expected to remain effective against viral mutations, including Omicron. Discussions for inclusion in a multinational trial and non-dilutive funding for further development are ongoing.
RedHill Biopharma Ltd. (NASDAQ:RDHL) completed an $8 million underwritten public offering, led by Aegis Capital Corp. as the sole bookrunner. The funds are aimed at supporting RedHill's ongoing clinical development programs, including RHB-204 for pulmonary NTM disease and opaganib for COVID-19 and oncology treatments. This offering aligns with RedHill's focus on gastrointestinal and infectious diseases, enhancing its potential for market growth and development of innovative therapies.
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