Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma announced positive preclinical results for opaganib, demonstrating its potential in protecting hematological and kidney functions post total body irradiation (TBI). These findings align with U.S. government-funded data supporting opaganib as a therapeutic for nuclear radiation injuries. The development plan may leverage the Animal Rule, allowing for potential expedited approval without human efficacy studies. Discussions for governmental support are ongoing, while opaganib's further development for COVID-19 and oncology continues, highlighting its versatile pipeline potential.

RedHill Biopharma (Nasdaq: RDHL) has announced accelerated development for opaganib as a potential therapeutic against nuclear radiation injury and for cancer radiotherapy. Recent studies published in the International Journal of Molecular Sciences indicate opaganib may protect normal tissue from radiation damage and enhance survival in irradiated subjects. The drug is an oral, stable, small molecule with a shelf-life exceeding five years, making it suitable for government stockpiling. Development plans include following the Animal Rule for FDA approval and discussions for government support are already underway.

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a non-binding agreement with HCR Collateral Management to transfer its rights in Movantik® (naloxegol) in exchange for cancelling all debt obligations under a Credit Agreement with HCR. RedHill will retain pre-closing liabilities related to Movantik while HCR will assume post-closing liabilities. The definitive agreements are expected to be signed soon, with closing anticipated by year-end, though certainty in completion remains uncertain. The agreement aims to ensure continuity in patient care during the transition.

RedHill Biopharma reported Q2 2022 net revenues of $18.3 million with an operating loss of $9.2 million. As of June 30, 2022, the cash balance stood at $43.2 million. Q3 2022 estimates project revenues between $16.5 million and $18.5 million, with losses between $5.5 million and $7.5 million. Prescription growth continues for Talicia® and Movantik®, with Talicia becoming the most prescribed H. pylori therapy. Ongoing negotiations regarding loan repayments and potential asset sales mark efforts to improve financial standing.

RedHill Biopharma (Nasdaq: RDHL) presented new analyses on Talicia at the Obesity Week Annual Meeting (Nov 1-4, 2022). These analyses indicate that Talicia's efficacy for eradicating H. pylori is not affected by elevated body mass index (BMI) or diabetes. Notably, Talicia achieved an 84% eradication rate compared to 58% for standard therapies. This positions Talicia as a first-line treatment for H. pylori, crucial given that the infection affects ~35% of U.S. adults. Talicia offers a favorable safety profile and demonstrates high intragastric concentrations, supporting its broad applicability in diverse patient populations.

RedHill Biopharma (Nasdaq: RDHL) presented new data analyses for its products Talicia and Movantik at the ACG Annual Meeting on October 21-26, 2022. A PBPK modeling study revealed that Talicia, a leading H. pylori treatment, provides superior intragastric antibiotic exposure with a dosing regimen of 50 mg rifabutin every 8 hours compared to standard rifabutin therapies. Movantik, the top oral PAMORA for opioid-induced constipation, demonstrated significant improvements in patient quality of life and symptom control in pooled analyses of phase 3 studies. RedHill emphasizes Talicia's efficacy in addressing antibiotic resistance issues.

RedHill Biopharma (NASDAQ: RDHL) announced that the United States Patent and Trademark Office granted a new method of use patent for opaganib, aimed at treating COVID-19 pneumonia in patients requiring supplemental oxygen (FiO2 up to 60%). This patent protects findings from a Phase 2/3 study, which revealed a 62% reduction in mortality among treated patients. RedHill continues its development of opaganib, focusing on pivotal Phase 3 trial preparations and potential funding opportunities for pandemic preparedness.

RedHill Biopharma (Nasdaq: RDHL) announced on October 12, 2022, that it received a notification from Nasdaq regarding a minimum bid price deficiency. The Company’s American Depositary Shares have closed below the required $1.00 per share for 30 consecutive business days. RedHill has until April 10, 2023, to regain compliance by maintaining a bid price of $1.00 or more for at least ten consecutive business days. The company will continue trading on Nasdaq and is assessing options to meet the listing requirements without immediate operational impacts.

RedHill Biopharma announced that its investigational antivirals, RHB-107 (upamostat) and opaganib, demonstrated in vitro effectiveness against the COVID-19 Omicron BA.5 variant. The results support their broad-acting, host-directed mechanisms, crucial for pandemic preparedness. Both drugs are undergoing further development, including Phase 3 trial designs and securing funding. Opaganib has shown a 70% mortality reduction in hospitalized patients, while RHB-107 reported a 100% reduction in hospitalization for non-hospitalized patients. The company plans to advance these candidates pending regulatory approvals.