Welcome to our dedicated page for Redhill Biopharma news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharma stock.
RedHill Biopharma Ltd. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
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.
RedHill Biopharma (Nasdaq: RDHL) announced preliminary results from a preclinical study indicating that opaganib, a novel SK2 selective inhibitor, significantly reduces thrombosis in an ARDS model. Administered at 250 mg/kg, opaganib demonstrated a reduction in blood clot length and weight, potentially benefiting COVID-19 patients at risk of ARDS-induced thrombosis. The company anticipates topline data from a U.S. Phase 2 study soon, following the completion of patient dosing on November 26, 2020. A larger global Phase 2/3 study is 60% enrolled, focusing on efficacy.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has been added to the NASDAQ Biotechnology Index, effective December 21, 2020. This index selection reflects the company's commitment to meeting specific eligibility criteria, including market capitalization and trading volume. The NASDAQ Biotechnology Index is significant as it underpins investment portfolios and evaluates biotech companies' performance. RedHill focuses on gastrointestinal and infectious diseases, with key products like Movantik® and Talicia®. More details can be found on their website.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced on December 7, 2020, that it has expanded the unrestricted national and regional commercial coverage for its drug Talicia® to over 40 million additional Americans, bringing total coverage to over 167 million. This expansion allows Talicia to reach over 70% of commercial lives and addresses high antibiotic resistance rates for H. pylori infections, which affect about 35% of the U.S. population. Talicia is a unique therapy that combines two antibiotics and a proton pump inhibitor, approved by the U.S. FDA in 2019.