Redhill Biopharm - RDHL STOCK NEWS

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.

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that CEO Dror Ben-Asher will present at the Morgan Stanley Annual Global Healthcare Conference on September 17, 2020. The conference runs from September 14-18, with various events planned. Other presentations include the PharmaVOICE 100 Celebration and the H.C. Wainwright 22nd Annual Healthcare Conference. These events will provide insights into RedHill's gastrointestinal drug developments, including Movantik, Talicia, and Aemcolo. All presentations will be available for replay on their website.

RedHill Biopharma (NASDAQ: RDHL) announced that its drug, opaganib, demonstrated complete inhibition of SARS-CoV-2 replication in an in vitro model, outperforming remdesivir, the study's positive control. Opaganib, an oral sphingosine kinase-2 inhibitor, exhibits potent antiviral and anti-inflammatory properties, targeting host cell components to reduce resistance likelihood. The company is advancing ongoing global Phase 2/3 and U.S. Phase 2 clinical studies for severe COVID-19 pneumonia. Additionally, RHB-107, a second candidate, showed similar antiviral efficacy and will enter a Phase 2/3 outpatient study.

RedHill Biopharma (RDHL) has announced that its drug candidate opaganib, which is undergoing clinical trials for severe COVID-19 pneumonia, has received a $300,000 grant from Pennsylvania's COVID-19 Vaccines, Treatments and Therapies Program. The funding will support research at Apogee Biotechnology, the company that licensed opaganib. The global Phase 2/3 study is ongoing, with patient enrollment in the UK, Italy, Russia, and Mexico. Opaganib aims to provide an effective therapeutic option for COVID-19, with promising preliminary results reported in earlier studies.

RedHill Biopharma (RDHL) has signed a term sheet with Cosmo Pharmaceuticals for a licensing and manufacturing agreement aimed at co-developing a new therapy for H. pylori infection. The agreement includes a $7 million upfront payment and 30% royalties for RedHill. Cosmo will also manufacture RedHill's Movantik® and RHB-204, with RedHill bearing 70% of the clinical trial costs. RHB-204 received FDA clearance for a Phase 3 study, with Cosmo set to finance related expenses. The deal strengthens RedHill's pipeline while enhancing Cosmo's manufacturing capabilities.

RedHill Biopharma has announced the approval of its Phase 2/3 clinical trial for opaganib, targeting severe COVID-19 patients. The trial will enroll up to 270 patients across multiple countries, including Mexico, the UK, and Russia. A parallel Phase 2 study in the U.S. is approximately 50% enrolled and expected to complete this month. If successful, the company plans to submit emergency use applications by Q4 2020. Preliminary results indicate positive outcomes in patients treated with opaganib under compassionate use, with no mechanical ventilation required for these patients.