Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the completion of treatment and follow-up for its 475-patient global Phase 2/3 study of opaganib (ABC294640) in hospitalized COVID-19 pneumonia patients. Top-line results are expected soon. Opaganib demonstrated strong in vitro activity against COVID-19 variants and has received positive Phase 2 efficacy data. The primary endpoint focuses on patients breathing room air without oxygen support by Day 14. The company is in discussions with regulatory bodies for approval pathways and potential partnerships.

RedHill Biopharma (Nasdaq: RDHL) announced that Movantik^® (naloxegol) has been added as an unrestricted preferred brand to a major national commercial formulary, effective July 1, 2021. This inclusion means over 30 million more Americans will gain access to Movantik, which treats opioid-induced constipation. Nearly 90% of U.S. commercial lives are now covered. Movantik's effectiveness and importance for pain management are emphasized, with ongoing efforts to expand formularies further. The safety information highlights potential gastrointestinal risks associated with Movantik usage.

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.