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 the approval of its global Phase 2/3 study for opaganib, a treatment for severe COVID-19 pneumonia, in Brazil. The study, now approved in six countries, aims to enroll up to 270 hospitalized patients. Opaganib has shown the ability to completely inhibit SARS-CoV-2 viral replication in human lung cells, exhibiting both antiviral and anti-inflammatory properties. Approximately 75% enrollment is achieved in the U.S. Phase 2 study, which continues to show promise. The company is pursuing global emergency use authorization contingent on favorable clinical outcomes.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that CEO Dror Ben-Asher will present at the Morgan Stanley Annual Global Healthcare Conference on September 17, 2020. The conference runs from September 14-18, with various events planned. Other presentations include the PharmaVOICE 100 Celebration and the H.C. Wainwright 22nd Annual Healthcare Conference. These events will provide insights into RedHill's gastrointestinal drug developments, including Movantik, Talicia, and Aemcolo. All presentations will be available for replay on their website.
RedHill Biopharma (NASDAQ: RDHL) announced that its drug, opaganib, demonstrated complete inhibition of SARS-CoV-2 replication in an in vitro model, outperforming remdesivir, the study's positive control. Opaganib, an oral sphingosine kinase-2 inhibitor, exhibits potent antiviral and anti-inflammatory properties, targeting host cell components to reduce resistance likelihood. The company is advancing ongoing global Phase 2/3 and U.S. Phase 2 clinical studies for severe COVID-19 pneumonia. Additionally, RHB-107, a second candidate, showed similar antiviral efficacy and will enter a Phase 2/3 outpatient study.
RedHill Biopharma (RDHL) has announced that its drug candidate opaganib, which is undergoing clinical trials for severe COVID-19 pneumonia, has received a $300,000 grant from Pennsylvania's COVID-19 Vaccines, Treatments and Therapies Program. The funding will support research at Apogee Biotechnology, the company that licensed opaganib. The global Phase 2/3 study is ongoing, with patient enrollment in the UK, Italy, Russia, and Mexico. Opaganib aims to provide an effective therapeutic option for COVID-19, with promising preliminary results reported in earlier studies.
RedHill Biopharma (RDHL) has signed a term sheet with Cosmo Pharmaceuticals for a licensing and manufacturing agreement aimed at co-developing a new therapy for H. pylori infection. The agreement includes a $7 million upfront payment and 30% royalties for RedHill. Cosmo will also manufacture RedHill's Movantik® and RHB-204, with RedHill bearing 70% of the clinical trial costs. RHB-204 received FDA clearance for a Phase 3 study, with Cosmo set to finance related expenses. The deal strengthens RedHill's pipeline while enhancing Cosmo's manufacturing capabilities.
RedHill Biopharma has announced the approval of its Phase 2/3 clinical trial for opaganib, targeting severe COVID-19 patients. The trial will enroll up to 270 patients across multiple countries, including Mexico, the UK, and Russia. A parallel Phase 2 study in the U.S. is approximately 50% enrolled and expected to complete this month. If successful, the company plans to submit emergency use applications by Q4 2020. Preliminary results indicate positive outcomes in patients treated with opaganib under compassionate use, with no mechanical ventilation required for these patients.