Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced it will report its third-quarter 2020 financial results on November 12, 2020. A conference call will be held at 8:30 a.m. EST, covering financial performance, commercial activities, and progress in its late-stage development program for opaganib targeting COVID-19, along with advancements in its pipeline, including the Phase 3 study for RHB-204 for pulmonary infections.

RedHill Biopharma (RDHL) has received a Notice of Allowance from the USPTO for a patent covering the combination of its investigational drugs, opaganib and RHB-107, for treating solid tumors, extending IP protection until 2036. A pre-clinical study on cholangiocarcinoma showed that both drugs individually and together induced tumor regression, with the combination being particularly effective. RedHill plans to introduce a third cohort in its Phase 2a study to evaluate this combination, pending FDA discussions, following preliminary positive results from the ongoing trial.

RedHill Biopharma presented compelling data on Talicia, its FDA-approved rifabutin-based therapy for H. pylori, at the ACG 2020 meeting. The Phase 3 trial revealed low eradication rates with clarithromycin-based regimens due to rising antibiotic resistance, highlighting the need for first-line treatments like Talicia. Importantly, Talicia's efficacy remained consistent across varying BMI levels, unlike traditional therapies, which saw a significant drop in effectiveness in obese patients. This positions Talicia as a superior option amid declining standard treatment success rates.

RedHill Biopharma (RDHL) announced that the FDA granted Orphan Drug Designation for RHB-204, aimed at treating pulmonary nontuberculous mycobacteria (NTM) disease. This designation extends U.S. market exclusivity for RHB-204 to 12 years, enhancing the urgency for new treatment options in a market lacking FDA-approved therapies. A Phase 3 study to evaluate RHB-204's safety and efficacy is set to begin soon, targeting 125 patients across 40 U.S. sites. The study will compare RHB-204 with a placebo, focusing on patient-reported outcomes and sputum culture conversion by Month 6.

RedHill Biopharma (RDHL) announced collaborations with European and Canadian pharmaceutical manufacturers to enhance opaganib production, a treatment for severe COVID-19 pneumonia. The global Phase 2/3 study is progressing rapidly with enrollments expected to reach 270 patients by year-end. The U.S. Phase 2 study is nearing completion and has passed a second independent review. Opaganib, an SK2 selective inhibitor, shows promising antiviral activity against SARS-CoV-2, which could support emergency use applications and address imminent demand.

RedHill Biopharma (RDHL) announced it has acquired the rights to Movantik (naloxegol) in Israel from AstraZeneca, securing global rights outside Europe and Canada. Movantik, approved for treating opioid-induced constipation, is not yet commercialized in Israel. RedHill is exploring local partnerships to bring the drug to market. In the U.S., RedHill holds exclusive commercialization rights and reported approximately $20 million in net revenue for Movantik in Q2 2020. RedHill aims to enhance margins and brand strategy for Movantik through recent agreements.

The independent Safety Monitoring Committee has recommended continuing the U.S. Phase 2 study of opaganib in COVID-19 without changes, as it is 75% enrolled. The study focuses on safety and will provide data later this quarter. Concurrently, a global Phase 2/3 study is rapidly enrolling in 15 sites, aiming for up to 270 patients and focusing on efficacy. The company is also seeking U.S. government funding to expedite opaganib's advancement towards potential emergency use authorization.

TEL AVIV, Israel and RALEIGH, N.C., Oct. 6, 2020 – RedHill Biopharma (Nasdaq: RDHL) announced its participation in two upcoming virtual conferences in October. The BIO Investor Forum will be held from Oct. 13-15, featuring Guy Goldberg, Chief Business Officer. Subsequently, the BIO-Europe 2020 conference will run from Oct. 26-29 with Adi Frish, Senior VP Business Development, as the speaker. Presentations will be accessible on the company's website for 30 days following each event.

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.