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 receipt of two Notices of Allowance from the USPTO for patents covering its COVID-19 treatments, opaganib and RHB-107, extending protection until at least 2041. Both oral therapies target viral replication and are expected to be effective against emerging variants. Recruitment for opaganib's Phase 2/3 study is nearly complete, while RHB-107's study is ongoing. The company is assessing regulatory paths for opaganib, focusing on countries severely affected by COVID-19, pending positive study data. The strength of safety and efficacy data is crucial for regulatory submissions.
RedHill Biopharma (Nasdaq: RDHL) presented new analyses of Movantik® at Digestive Disease Week 2021, showcasing its rapid onset and sustained efficacy in treating opioid-induced constipation (OIC). The studies pooled data from 891 patients, indicating significant symptom relief compared to 546 in placebo groups. Prof. William D. Chey highlighted the importance of early relief for OIC sufferers, which affects 40-80% of chronic opioid users. Movantik is crucial for pain management, countering one of the main side effects of opioid therapy.
RedHill Biopharma (Nasdaq: RDHL) presented a new Travelers' Diarrhea (TD) severity classification tool at Digestive Disease Week 2021, developed with the University of Texas School of Public Health. This tool aims to enhance clinical practice by providing clear separation of TD severity categories. The efficacy of Aemcolo (rifamycin) was confirmed through this tool, showing high effectiveness in moderate to severe TD cases. Aemcolo is noteworthy for its non-systemic delivery, resulting in limited side effects. This advancement could boost demand as travel resumes post-COVID.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will announce its first quarter 2021 financial results and operational highlights on May 27, 2021. A live webcast is scheduled for 8:30 a.m. EDT on the same day, allowing stakeholders to access key information, including performance metrics. RedHill focuses on gastrointestinal and infectious diseases, with products like Movantik, Talicia, and Aemcolo. Its ongoing clinical programs include RHB-204 for pulmonary NTM disease and opaganib for COVID-19 treatment.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a positive fourth review from the independent Data Safety Monitoring Board (DSMB) regarding its Phase 2/3 study of opaganib (Yeliva®) in hospitalized COVID-19 patients. The recommendation was based on safety data from 255 patients, enlarging the safety database to 380. The study is over 75% enrolled across 40 sites. Positive earlier Phase 2 data showed opaganib's effectiveness in reducing oxygen requirements without significant safety differences compared to placebo. Top-line results from the study are anticipated soon.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a settlement with MSN Pharmaceuticals regarding patent litigation for Movantik® (naloxegol). The agreement prohibits MSN from marketing a generic version in the U.S. until October 1, 2030, unless conditions allow earlier entry. RedHill acquired Movantik rights in April 2020 and aims to protect its interests in ongoing litigation against other ANDA filers. This settlement may impact RedHill's market position as it retains exclusivity for Movantik until the settlement date.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the compassionate use treatment of opaganib for COVID-19 pneumonia patients in Switzerland. This oral sphingosine kinase-2 inhibitor has shown anti-inflammatory and antiviral properties. The company recently reported positive Phase 2 data in the U.S. and is two-thirds enrolled in a global Phase 2/3 study involving 464 patients. Opaganib, which has shown potential against SARS-CoV-2, aims to address severe COVID-19 cases as well as other oncology and inflammatory conditions.
RedHill Biopharma reported 2020 financial results with net revenues of approximately $64 million, marking a significant increase of $58 million from 2019, driven by Movantik and Talicia sales. Gross profit stood at $27.5 million. Despite strong growth, the company faced an operating loss of approximately $64 million and a net loss of about $76 million. The company's cash balance was solid at $100 million as of March 2021. RedHill is progressing in COVID-19 therapeutics with two Phase 2/3 studies for Opaganib and RHB-107, expecting to achieve commercial operational breakeven by the end of 2021.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its fourth quarter and full year 2020 financial results on March 18, 2021, during a conference call at 8:30 a.m. EDT. Highlights will include the company's full-year financial performance and ongoing clinical studies, particularly for COVID-19 treatments opaganib and RHB-107, as well as a Phase 3 study for RHB-204 targeting pulmonary nontuberculous mycobacteria disease.
The webcast will be available live on the company's website.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its fourth quarter and full year 2020 financial results on March 18, 2021, at 8:30 a.m. EDT.
The company will detail 2020 financial performance, commercial activities, and updates on ongoing clinical studies for COVID-19 treatments (opaganib and RHB-107) and a Phase 3 study of RHB-204 for pulmonary nontuberculous mycobacteria.
The webcast will be available live on the company’s website and for replay for 30 days.