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 (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.
RedHill Biopharma (Nasdaq: RDHL) has successfully closed an underwritten public offering, generating approximately $8.0 million in gross proceeds. The offering comprised 32 million units, each priced at $0.25, including one American Depositary Share (ADS) and one warrant to purchase another ADS. The funds will be allocated for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. served as the sole book-running manager for this offering.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a public offering priced at approximately $8.0 million, consisting of 32 million units of American Depositary Shares (ADS) and associated warrants at a price of $0.25 per ADS. The offering is set to close on December 6, 2022, subject to customary conditions. The net proceeds will be used for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. is the book-running manager for this offering, conducted under a shelf registration statement declared effective by the SEC.
RedHill Biopharma (Nasdaq: RDHL) announced a proposed underwritten public offering of American Depositary Shares (ADSs) and warrants to purchase ADSs. The Company plans to use net proceeds for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. is acting as the sole book-running manager. The offering is subject to market conditions and is detailed in a shelf registration statement declared effective by the SEC.