Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma (Nasdaq: RDHL) announced a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib for severe COVID-19, based on a pre-scheduled review of efficacy and safety data. Opaganib has shown potential against viral resistance and has demonstrated improvements in reducing oxygen needs in patients. The study will expand to around 460 patients across 30 sites in 7 countries, with top-line data expected in Q2 2021 and potential emergency use applications.

RedHill Biopharma (Nasdaq: RDHL) has partnered with Cosmo Pharmaceuticals to expand manufacturing capacity for opaganib (Yeliva^®), targeting increased demand following potential global emergency use authorizations. Opaganib is a novel SK2 inhibitor aimed at treating COVID-19 pneumonia and has demonstrated efficacy against viral strains. An interim analysis of a Phase 2/3 study is imminent, with promising preliminary safety and efficacy data reported from an earlier Phase 2 trial. The drug holds Orphan Drug designation from the FDA for cholangiocarcinoma.

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the closing of a $25 million underwritten offering of 3,188,776 American Depositary Shares (ADSs) at $7.84 each. The offering was managed by H.C. Wainwright & Co., with a 30-day option for the underwriter to purchase an additional 478,316 ADSs. Proceeds will be utilized for clinical development, commercialization activities, acquisitions, and general corporate purposes. The securities were registered under a prior shelf registration statement with the SEC.

RedHill Biopharma (Nasdaq: RDHL) has expanded its previously announced offering, purchasing 3,188,776 American Depositary Shares (ADSs) at $7.84 each, totaling approximately $25 million in gross proceeds. The closing is anticipated by January 14, 2021, subject to standard conditions. Additionally, the underwriter holds a 30-day option for purchasing up to 478,316 more ADSs. Proceeds will be allocated to clinical development, commercialization, acquisitions, and general corporate purposes, enhancing the company's financial position in the biopharmaceutical sector.

RedHill Biopharma (Nasdaq: RDHL) announced a firm commitment underwriting agreement with H.C. Wainwright & Co. for 1,275,510 American Depositary Shares (ADSs) at $7.84 per ADS, expecting gross proceeds of approximately $10 million. The offering is projected to close around January 14, 2021, subject to customary conditions. Additionally, the underwriter holds a 30-day option for 191,326 additional ADSs. Proceeds will be allocated to clinical development, commercialization activities, and general corporate purposes.

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that its partner, Cosmo Pharmaceuticals, successfully completed a Phase 2 study of Rifamycin SV-MMX 600mg for diarrhea-predominant irritable bowel syndrome (IBS-D). The trial showed statistically significant results in reducing pain and diarrhea, as well as improving IBS-related symptoms. RedHill holds specific rights regarding the product in the U.S. under a 2019 licensing agreement. The outcome suggests that Rifamycin SV-MMX may be a promising treatment option for IBS-D if it receives regulatory approval.

RedHill Biopharma (Nasdaq: RDHL) announced that RHB-204 received Fast Track designation from the FDA for treating pulmonary nontuberculous mycobacteria (NTM) disease, caused by Mycobacterium avium Complex. This designation aims to expedite the development and review of essential therapies for serious diseases without approved treatments. RHB-204 has also been granted Orphan Drug designation, potentially extending market exclusivity to 12 years. A Phase 3 study is underway, evaluating RHB-204 across 40 U.S. sites.

RedHill Biopharma (Nasdaq: RDHL) reported positive top-line data from its U.S. Phase 2 study of opaganib, an oral treatment for COVID-19 pneumonia. The study involved 40 patients requiring oxygen support and showed no significant safety differences compared to placebo. Key findings included a higher percentage of patients no longer needing oxygen support (52.6% vs. 22.2%), as well as improved discharge rates and oxygen requirement reductions. Further analyses are forthcoming, and a global Phase 2/3 study is ongoing, with expected results in Q1 2021.

RedHill Biopharma (Nasdaq: RDHL) announced a unanimous recommendation from the Data Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib in severe COVID-19 pneumonia after safety data analysis from 155 patients. Enrollment is over 60% complete, with top-line data expected in Q1 2021. The Phase 2 U.S. study has completed 40 subject enrollments, focusing on safety. Opaganib is a novel oral SK2 selective inhibitor that targets the viral replication process and has shown potential in treating multiple conditions, including cholangiocarcinoma and prostate cancer.