Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma announced that its drug Talicia® has been added to the Medi-Cal Contract Drug List without prior authorization requirements, effective October 1, 2021. This addition provides coverage for approximately two million patients in California, enhancing accessibility for H. pylori treatment. Talicia is the only FDA-approved rifabutin-based therapy for H. pylori infections, addressing the resistance seen with standard therapies. The drug offers an impressive 84% eradication rate in clinical trials, with strong market exclusivity until 2034.

RedHill Biopharma (Nasdaq: RDHL) announced that Medi-Cal, California's Medicaid program, added its drug Talicia^® (omeprazole magnesium, amoxicillin, and rifabutin) to its Contract Drug List effective October 1, 2021. This change allows for easier access for approximately two million patients as no prior authorization is required for treatment of H. pylori infections. Talicia^® is significant due to its effectiveness against antibiotic-resistant strains and has shown an 84% eradication rate in clinical trials. The drug holds U.S. market exclusivity until 2027 under its Qualified Infectious Disease Product designation.

RedHill Biopharma (Nasdaq: RDHL) reported positive findings from a Phase 2/3 study of its oral drug opaganib in hospitalized COVID-19 patients. The analysis showed a 62% reduction in mortality among those treated compared to the placebo group. Key outcomes included 77% of opaganib patients reaching room air by Day 14 and a median discharge time of 10 days versus 14 days for placebo, suggesting significant clinical benefits. The company plans to discuss these results with regulators to determine future steps for opaganib as a potential treatment for severe COVID-19.

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.