Redhill Biopharm - RDHL STOCK NEWS

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that the U.S. FDA has cleared its IND application for RHB-107 (upamostat) to enter Phase 2/3 trials in patients with symptomatic COVID-19 who do not require hospitalization. This milestone aims to address COVID-19 treatment earlier in the disease course, using an oral therapy, which is significant given the large number of symptomatic patients at risk. The trial plans to enroll patients early next year, targeting recovery time and assessing safety alongside other endpoints.

RedHill Biopharma (Nasdaq: RDHL) has completed patient enrollment for its U.S. Phase 2 study of opaganib (Yeliva®) targeting severe COVID-19 pneumonia. This study, which is not powered for statistical significance, aims to evaluate safety and gather efficacy signals, with topline data expected soon. Concurrently, a global Phase 2/3 study is around 50% enrolled, with initial safety analysis anticipated shortly. Opaganib uniquely targets viral replication mechanisms, potentially minimizing resistance issues, and aims for emergency use applications based on positive outcomes.

RedHill Biopharma (Nasdaq: RDHL) announced that Chief Business Officer Guy Goldberg will present a corporate overview and participate in 1-on-1 investor meetings at the German Equity Forum 2020 on November 17, 2020, at 9:30 a.m. CET. The event is among Europe’s largest investor gatherings. A replay of the presentation will be available for 30 days on the Company's website. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs such as Movantik and Talicia.

RedHill Biopharma reported Q3 2020 net revenues of approximately $21 million with a gross profit of $10.6 million, representing a 51% gross margin, up from 32% in Q2 2020. Talicia® saw exceptional growth with a 300% quarter-over-quarter increase in prescriptions. Movantik® also reversed its declining trend with two consecutive quarters of prescription growth. The Company is advancing studies for opaganib in COVID-19, nearing 50% enrollment for global trials. As of September 30, 2020, RedHill's cash balance was approximately $51 million.

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.