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. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
RedHill Biopharma (Nasdaq: RDHL) announced a settlement and license agreement with Aurobindo Pharma regarding the patent litigation for Movantik® (naloxegol). The agreement prevents Aurobindo from selling a generic version in the U.S. until April 1, 2031, pending FDA approval. RedHill acquired global rights to Movantik from AstraZeneca in April 2020, excluding Europe and Canada. The settlement concludes all ongoing Hatch-Waxman patent litigations against ANDA filers prior to patent expiration.
RedHill Biopharma (Nasdaq: RDHL) has announced preliminary top-line data from its 475-patient Phase 2/3 study of opaganib in hospitalized patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint, though trends indicated potential benefits of opaganib compared to placebo. Safety data showed good tolerability with a balance of adverse events. The findings suggest exploring opaganib's use in earlier disease stages. The company plans further discussions with regulators regarding next steps and ongoing studies.
RedHill Biopharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for a Phase 2/3 study of RHB-107 (upamostat), aimed at treating non-hospitalized symptomatic COVID-19 patients. This approval comes as the U.S. study expands its site locations to enhance patient recruitment. RHB-107, an oral antiviral targeting serine proteases, shows promise against emerging viral variants with prior studies demonstrating clinical safety. Concurrently, opaganib is being evaluated in a global Phase 2/3 trial for severe COVID-19.
RedHill Biopharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Phase 2/3 study of RHB-107 (upamostat), an oral treatment for symptomatic COVID-19 patients not requiring hospitalization. The study aims to assess the safety and efficacy of RHB-107, with expanded U.S. sites to boost patient recruitment. RHB-107 targets viral entry through human cell factors and shows promise against emerging variants. Concurrently, the company is awaiting top-line results from its opaganib study for severe COVID-19 cases.
RedHill Biopharma (Nasdaq: RDHL) announced promising results from a preclinical study demonstrating that opaganib (ABC294640) significantly decreases renal fibrosis in a model of kidney damage. This condition, which can lead to acute renal failure, poses risks especially for COVID-19 patients. The study highlights opaganib's potential as a therapeutic option for chronic kidney disease and acute kidney injury associated with COVID-19, potentially benefiting millions of patients. Key upcoming data from the global Phase 2/3 study will further evaluate its effectiveness in hospitalized COVID-19 patients.
RedHill Biopharma (NASDAQ:RDHL) presented three new analyses of Movantik (naloxegol) data at PAINWeek 2021, focusing on its efficacy in patients aged ≥65 and across varying opioid doses. The analyses showed Movantik's superior response rates compared to placebo, providing rapid relief from opioid-induced constipation (OIC). Data pooled from two Phase 3 studies involved 891 patients treated with Movantik and 446 in the placebo group. The findings underscore the importance of managing OIC, especially in older patients who frequently receive opioid therapy.
RedHill Biopharma (Nasdaq: RDHL) presented new analyses of Movantik (naloxegol) data at PAINWeek 2021, demonstrating its rapid efficacy for opioid-induced constipation (OIC) in patients aged 65 and older, along with all opioid doses. The pooled data from two Phase 3 studies involved 891 patients, indicating that Movantik significantly improves bowel movement rates compared to placebo. With a high prevalence of OIC among elderly opioid users, these findings underscore Movantik's role in pain management without added constipation issues, as emphasized by leading researchers.
RedHill Biopharma (NASDAQ: RDHL) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021, where Guy Goldberg, Chief Business Officer, will present. Additionally, RedHill will be featured in a fireside chat at the Cantor Global Healthcare Conference on September 30, 2021. Both events will be accessible via webcast on the company's website for 30 days post-event, underscoring RedHill's focus on advancing treatments for gastrointestinal and infectious diseases.
RedHill Biopharma (Nasdaq: RDHL), a specialty biopharmaceutical company, announces participation in two virtual conferences in September 2021. At the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Guy Goldberg, Chief Business Officer, will present. The Cantor Global Healthcare Conference will feature a fireside chat on September 30 with Goldberg. Webcasts will be accessible for 30 days on RedHill's Investors page. RedHill focuses on gastrointestinal and infectious diseases, with key products including Movantik®, Talicia®, and Aemcolo®.
RedHill Biopharma reported record quarterly revenues of $21.5 million for Q2 2021, reflecting a 4.5% increase from Q1 2021 despite challenges. The cash balance was approximately $71.5 million as of June 30, 2021. Prescription volumes for Talicia rose over 10% and for Movantik increased 5.6%, with improved coverage for both drugs. Opaganib has shown promising results against COVID-19 variants and is under final selection by BARDA for the I-SPY trial. The company reported operational losses, primarily due to rising expenses related to COVID-19 programs and marketing.