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) reported positive top-line data from its U.S. Phase 2 study of opaganib, an oral treatment for COVID-19 pneumonia. The study involved 40 patients requiring oxygen support and showed no significant safety differences compared to placebo. Key findings included a higher percentage of patients no longer needing oxygen support (52.6% vs. 22.2%), as well as improved discharge rates and oxygen requirement reductions. Further analyses are forthcoming, and a global Phase 2/3 study is ongoing, with expected results in Q1 2021.
RedHill Biopharma (Nasdaq: RDHL) announced a unanimous recommendation from the Data Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib in severe COVID-19 pneumonia after safety data analysis from 155 patients. Enrollment is over 60% complete, with top-line data expected in Q1 2021. The Phase 2 U.S. study has completed 40 subject enrollments, focusing on safety. Opaganib is a novel oral SK2 selective inhibitor that targets the viral replication process and has shown potential in treating multiple conditions, including cholangiocarcinoma and prostate cancer.
RedHill Biopharma (Nasdaq: RDHL) announced preliminary results from a preclinical study indicating that opaganib, a novel SK2 selective inhibitor, significantly reduces thrombosis in an ARDS model. Administered at 250 mg/kg, opaganib demonstrated a reduction in blood clot length and weight, potentially benefiting COVID-19 patients at risk of ARDS-induced thrombosis. The company anticipates topline data from a U.S. Phase 2 study soon, following the completion of patient dosing on November 26, 2020. A larger global Phase 2/3 study is 60% enrolled, focusing on efficacy.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has been added to the NASDAQ Biotechnology Index, effective December 21, 2020. This index selection reflects the company's commitment to meeting specific eligibility criteria, including market capitalization and trading volume. The NASDAQ Biotechnology Index is significant as it underpins investment portfolios and evaluates biotech companies' performance. RedHill focuses on gastrointestinal and infectious diseases, with key products like Movantik® and Talicia®. More details can be found on their website.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced on December 7, 2020, that it has expanded the unrestricted national and regional commercial coverage for its drug Talicia® to over 40 million additional Americans, bringing total coverage to over 167 million. This expansion allows Talicia to reach over 70% of commercial lives and addresses high antibiotic resistance rates for H. pylori infections, which affect about 35% of the U.S. population. Talicia is a unique therapy that combines two antibiotics and a proton pump inhibitor, approved by the U.S. FDA in 2019.
RedHill Biopharma (Nasdaq: RDHL) announced partnerships with two U.S. manufacturers to scale up production of opaganib, an oral treatment for severe COVID-19 pneumonia, ahead of potential emergency use applications expected in Q1 2021. The company has also secured collaborations with European and Canadian manufacturers. Currently, a global Phase 2/3 study is over 50% enrolled, aiming for top-line data soon. Opaganib targets the SK2 enzyme, showing promise in reducing viral replication and lung inflammation, with additional studies for cancer treatment ongoing.
RedHill Biopharma (Nasdaq: RDHL) announced its participation in two virtual healthcare conferences in December 2020. The Evercore ISI 3rd Annual HealthCONx Conference is scheduled for December 3, featuring a fireside chat with CEO Dror Ben-Asher and COO Gilead Raday. Additionally, the Piper Sandler 32nd Annual Virtual Healthcare Conference will offer an on-demand fireside chat starting November 23. RedHill, focused on gastrointestinal and infectious diseases, is known for its drugs Movantik®, Talicia®, and Aemcolo® and ongoing late-stage clinical programs.
RedHill Biopharma (Nasdaq: RDHL) has initiated a Phase 3 study to evaluate RHB-204 for the treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex. This disease currently lacks an FDA-approved first-line therapy, with around 110,000 cases reported in the U.S. The study will enroll 125 patients across 40 sites, assessing safety and efficacy over 6 months, with potential continuation for 16 months. RHB-204 has received Orphan Drug and Qualified Infectious Disease Product designations, extending market exclusivity up to 12 years upon FDA approval.
RedHill Biopharma (RDHL) announced a unanimous recommendation from an independent Data and Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib in treating severe COVID-19 pneumonia. This recommendation follows a review of safety data from the first 70 patients treated over 14 days. The study, which is more than 50% enrolled with 270 patients, aims to provide efficacy data expected in Q1 2021. A companion U.S. Phase 2 study has completed enrollment. Opaganib holds promise due to its dual anti-inflammatory and antiviral properties.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that the U.S. FDA has cleared its IND application for RHB-107 (upamostat) to enter Phase 2/3 trials in patients with symptomatic COVID-19 who do not require hospitalization. This milestone aims to address COVID-19 treatment earlier in the disease course, using an oral therapy, which is significant given the large number of symptomatic patients at risk. The trial plans to enroll patients early next year, targeting recovery time and assessing safety alongside other endpoints.