Welcome to our dedicated page for Redhill Biopharma news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharma 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 preliminary results from a preclinical study showing that opaganib effectively inhibits the Beta and Gamma COVID-19 variants. This investigational oral drug targets sphingosine kinase-2 (SK2), crucial for viral replication. The global Phase 2/3 study of opaganib, fully enrolled with 475 patients, is nearing completion, with encouraging preliminary safety and efficacy data. Opaganib's dual mechanism combines antiviral and anti-inflammatory effects, showing potential against emerging COVID-19 variants.
RedHill Biopharma (RDHL) announced positive Phase 2 data for oral opaganib (Yeliva®) in hospitalized COVID-19 patients at the World Microbe Forum. In a 40-patient study, 50% of opaganib recipients reached room air by Day 14, compared to 22% for placebo. Additionally, 86.4% of opaganib patients were discharged by Day 14 versus 55.6% for placebo. Median discharge time was 6 days for opaganib versus 7.5 days for placebo. No significant safety issues were noted. Following the completion of a 475-patient global Phase 2/3 study, further data is expected soon.
RedHill Biopharma (Nasdaq: RDHL) announced that Adi Frish, Chief Corporate & Business Development Officer, will present a corporate overview at the BIO Digital International Convention from June 14-18, 2021. The presentation will be accessible on the company’s website for 30 days post-conference. RedHill specializes in treatments for gastrointestinal and infectious diseases, including Movantik®, Talicia®, and Aemcolo®. Key clinical programs include RHB-204 for pulmonary NTM disease and others targeting COVID-19 and cancers. More at redhillbio.com.
RedHill Biopharma (Nasdaq: RDHL) announced the completion of patient enrollment in its global Phase 2/3 study of opaganib (Yeliva®, ABC294640) for treating severe COVID-19 pneumonia, exceeding its target with 475 randomized patients. The study's primary endpoint aims to assess the proportion of patients breathing independently by Day 14. Preliminary data suggests encouraging intubation and mortality rates compared to larger studies. Ongoing discussions with regulatory authorities and potential partners are underway to evaluate the next steps for opaganib's market introduction.
RedHill Biopharma reported Q1 2021 financial results with net revenues of approximately $20.6 million, down $0.9 million from Q4 2020. Gross profit decreased slightly to $10.3 million, maintaining a 50% gross margin. R&D expenses rose to $7.5 million due to COVID-19 programs. Operating loss was $18.2 million, while net loss totaled $22.9 million. Cash balance stood at $92.1 million. The company highlighted progress in COVID-19 programs with Opaganib nearly fully enrolled in a Phase 2/3 study.
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.