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 announced that its drug Opaganib operates through a unique mechanism, targeting human host cells rather than the virus, making it likely effective against Omicron and other variants. Regulatory submissions for Opaganib are in progress, with initial feedback expected from the U.S. FDA in January 2022 and from the European Medicines Agency by the end of 2021. Furthermore, RHB-107, another COVID-19 treatment, is awaiting top-line data early next year. Positive clinical data suggest Opaganib could significantly reduce mortality in moderately severe COVID-19 patients.
RedHill Biopharma (Nasdaq: RDHL) announced that its drug Opaganib targets human host cells, making it effective against COVID-19 variants like Omicron. The company has submitted global Phase 2/3 data to the EMA, FDA, and UK MHRA, with feedback expected soon. Opaganib may significantly benefit hospitalized patients with advanced disease, as treatment starts later than conventional options like Pfizer and Merck. The company is also advancing RHB-107, another antiviral targeting COVID-19, with top-line data anticipated in Q1 2022.
RedHill Biopharma has published new data in the journal GastroHep showing that its drug Talicia achieves high eradication rates for H. pylori infection, irrespective of patient BMI. In a post-hoc analysis of 269 patients, eradication rates reached 88.1% for patients with BMI >30 kg/m² and 90.9% for those with BMI >40 kg/m², compared to active comparators at 62.9% and 31.8% respectively. Talicia is FDA approved as a first-line therapy, offering a promising option for treating H. pylori in overweight and obese populations.
RedHill Biopharma (Nasdaq: RDHL) announced a study published in GastroHep showing that Talicia® effectively eradicates Helicobacter pylori across all body mass index (BMI) groups, including obese patients. The study analyzed data from 269 patients in Phase 3 trials and found eradication rates of approximately 90% for those with BMI over 30 kg/m², significantly outperforming active comparators. Talicia's low resistance rate compared to clarithromycin further underscores its potential as a first-line therapy, especially as obesity is a major risk factor for treatment failure.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that Movantik® (naloxegol) has been approved as a preferred and unrestricted brand on a major National Medicare Part D formulary, effective January 1, 2022. This inclusion allows over 10 million Americans access to Movantik for treating opioid-induced constipation. With this approval, Movantik now achieves coverage of 90% of U.S. commercial lives and over 94% of Medicare Part D lives. The company emphasizes the importance of managing constipation associated with opioid use for effective chronic pain management.
RedHill Biopharma announced that its product Movantik (naloxegol) is now preferred and unrestricted on a major National Medicare Part D formulary, effective January 1, 2022. This inclusion expands Movantik's coverage, reaching over 10 million additional Americans and increasing total commercial coverage to 152 million. The drug is the leading treatment for opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
RedHill Biopharma (RDHL) reported its operational highlights and financial results for Q3 2021, achieving record net revenues of $21.6 million. The company saw a 15% increase in new prescriptions for Talicia and 1.1% for Movantik. The gross margin improved from 51% to 57%, and operating loss decreased to $17.4 million from $24.9 million. Notably, opaganib demonstrated a 62% reduction in mortality in a post-hoc analysis of COVID-19 patients. Cash balance stood at $51.5 million as of September 30, 2021, bolstered by strategic investments and a public offering.
RedHill Biopharma (RDHL) is accelerating its COVID-19 clinical programs for opaganib and RHB-107, showcasing their efficacy against the Omicron variant. A Phase 2/3 analysis revealed a 62% mortality reduction in moderately severe patients treated with opaganib. The company reported Q3 2021 net revenues of $21.6 million, with a gross margin increase to 57%. New strategic investments and a $15.5 million public offering bolster its financial position, while Talicia and Movantik continue to see prescription growth, with Talicia's revenue up 117% compared to Q3 2020.
RedHill Biopharma (Nasdaq: RDHL) will announce its Q3 2021 financial results and operational highlights on November 30, 2021. A webcast is scheduled for 8:30 a.m. EST, where key highlights will be presented. The webcast will be available for replay for 30 days. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs like Movantik, Talicia, and Aemcolo. Ongoing clinical developments include RHB-204 for NTM disease and opaganib targeting COVID-19.
On November 23, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the closing of an underwritten public offering of approximately 4.7 million American Depositary Shares (ADSs), raising about $15.5 million in gross proceeds. Each ADS represents ten ordinary shares and was offered by RedHill, which has granted a 30-day option to purchase approximately 0.7 million additional ADSs. The funds will support commercialization activities, clinical development programs, and general corporate purposes.