Nachrichten und Videos - REDHILL BIOPHARMA

RedHill Biopharma Receives Nasdaq Notification Regarding Minimum Stockholders' Equity Deficiency PR Newswire TEL AVIV, Israel and RALEIGH, N.C., April 17, 2025 The Notification Letter has no immediate effect on the Company's listing on the Nasdaq Capital Market at this time, nor are the Company's business operations affected by receipt of the Notification Letter TEL AVIV, Israel and RALEIGH, N.C. , April 17, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"),...

RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption PR Newswire TEL AVIV, Israel and RALEIGH, N.C., April 16, 2025 GLP-1 comparable efficacy: Opaganib's positive results, newly published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models -- Novel mechanism of action, formulation and administration: Opaganib is a...

RedHill Biopharma Announces Full-Year 2024 Financial Results and Operational Highlights PR Newswire TEL AVIV, Israel and RALEIGH, N.C., April 10, 2025 Revenue-generating with an exciting, diversified, largely externally funded, advanced development pipeline and multiple upcoming catalysts. Recent highlights: Global licensing deal (excluding North America ) with Hyloris Pharmaceuticals with RHB-102 for up to $60 million in potential milestone payments Approximately $8 million plus legal costs NY...

RedHill Biopharma to Submit FDA-Approved Talicia® for UK Marketing Authorisation PR Newswire RALEIGH, N.C., March 18, 2025 RedHill plans to submit UK MAA 1 for Talicia for H. pylori infection, using MHRA's 2 new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG 3 Clinical Guideline as a first-line option, Talicia is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose...

RedHill Biopharma Advances its Groundbreaking Late-Stage Crohn's Disease Program Building on Statistically Significant Positive RHB-104 Phase 3 Results PR Newswire RALEIGH, N.C. and TEL-AVIV, Israel, March 12, 2025 The planned innovative Phase 2 study of RHB-204 1 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP 2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on...

RedHill Presents Business Update at the Sachs' European Life Sciences CEO Forum PR Newswire RALEIGH, N.C. and TEL-AVIV, Israel, Feb. 27, 2025 Guy Goldberg , RedHill's Chief Business Officer, presents today a business update at the European Life Sciences CEO Forum The update covers: The recent out-licensing of RHB-102 [1] to Hyloris (Euronext Brussels: HYL) in a potential $60 million plus royalties deal Initiation of the Bayer-funded Phase 2 clinical study of opaganib [2] in combination with...

RedHill Licenses RHB-102 for Commercialization Worldwide Excluding North America to Hyloris for up to $60 Million in Potential Milestone Payments Plus Royalties PR Newswire TEL AVIV, Israel and RALEIGH, N.C., Feb. 25, 2025 - Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, in return for exclusive rights to develop and commercialize RHB-102 (Bekinda ® ) across all indications and territories...

RedHill Announces Initiation of Phase 2 Study of Opaganib and Darolutamide in Advanced Prostate Cancer PR Newswire TEL-AVIV, Israel and RALEIGH, N.C., Feb. 4, 2025 The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC) , testing the potentially enhancing effect of opaganib in patients with a poor prognosis The study is being financially supported...

RedHill's Talicia® Adds 8 Million Lives With Coverage by Humana®'s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published PR Newswire RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 21, 2025 Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization The recently updated American College of Gastroenterology (ACG)...

Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development PR Newswire TEL AVIV, Israel and RALEIGH, N.C., Dec. 10, 2024 Heightened geopolitical tensions and Homeland Security concerns call for the development of potential therapies that can be quickly and easily mobilized in the event of a mass casualty nuclear or radiological incident There are currently no known approved therapies for...

RedHill Biopharma Awarded Judgment of Approximately $8 Million Plus Costs by New York Supreme Court PR Newswire TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2024 RedHill has been awarded a judgment of approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd The Court dismissed the entirety of Kukbo's counterclaims, ruling in favor of RedHill's demonstrated good faith commitment to the spirit and the letter of the...

RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND PR Newswire TEL-AVIV, Israel and RALEIGH, N.C., Oct. 28, 2024 RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day" -- Based on reviews, feedback, and discussion, the judges...

RedHill Announces Collaboration with a Leading U.S. Academic Medical Center to Develop Opaganib as a Countermeasure Against Phosgene Inhalation Injury PR Newswire TEL AVIV, Israel and RALEIGH, N.C., Oct. 22, 2024 The collaboration outlines plans for multiple in vivo studies, designed to test opaganib as a potential medical countermeasure to treat phosgene inhalation injury. The collaboration aims to determine whether opaganib can advance into further definitive U.S. government-sponsored...

RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment PR Newswire TEL-AVIV, Israel and RALEIGH, N.C., Oct. 14, 2024 The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat Ebola virus disease (EBOV) -- The funding advances opaganib's positive development progress to date on the expected FDA Animal Rule pathway toward potential...

RedHill and Medi-Cal Deal Maintains Talicia® Reimbursement Without Prior Authorization for 15 Million Californians PR Newswire RALEIGH, N.C. and TEL AVIV, Israel, Oct. 1, 2024 Medi-Cal, California's Medicaid healthcare program, and RedHill have renewed their contract to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization and a $0 copay – a major benefit for approximately fifteen million Californian Medi-Cal patients...

RedHill Announces New U.S. Coronavirus Patent for Opaganib, Valid Through 2041 PR Newswire TEL-AVIV, Israel and RALEIGH, N.C., Sept. 30, 2024 New U.S. patent issued covering the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO 2 )) prognostic for potential opaganib efficacy in treating COVID-19, valid through 204 Published post-hoc data from opaganib's Phase2/3 study showed that patients with ≤60% FiO 2 levels had better outcomes after 14...

RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines PR Newswire RALEIGH, N.C. and TEL-AVIV, Israel, Sept. 9, 2024 First new American College of Gastroenterology (ACG) Clinical Guideline [1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of...

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement PR Newswire TEL AVIV, Israel and RALEIGH, N.C., Sept. 5, 2024 TEL AVIV, Israel and RALEIGH, N.C. , Sept. 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from the Listings Qualifications Department of The Nasdaq Stock Market LLC (the "Listings Qualifications Department") that the Company had...

New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality PR Newswire TEL AVIV, Israel and RALEIGH, N.C., Sept. 3, 2024 Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms The...

RedHill Biopharma Announces First Half 2024 Business Highlights PR Newswire TEL AVIV, Israel and RALEIGH, N.C., Aug. 29, 2024 A transformed RedHill : Numerous potential catalysts Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others : Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base U.S. government collaborations : Developing a promising,...