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Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths [1], [2] Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits The neuroblastoma market is expected to reach almost $1.5 billion before mid-2030s [3] This is the second orphan drug designation by the FDA for opaganib in oncology, after cholangiocarcinoma (bile duct cancer, CCA) With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles TEL AVIV, Israel and RALEIGH, N.C.
RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H.
On Monday, RedHill Biopharma Ltd. RDHL released results from multiple in vivo studies, undertaken by RedHill's partner, Apogee Biotechnology Corporation.
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 [1] – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity® and Mounjaro® and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance® -- Positive results from multiple in vivo studies show the impact of sphingosine kinase-2 (SPHK2) inhibition in various models of metabolic disease, supporting the potential of opaganib therapy for diabetes and obesity-related disorders -- With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection
TEL AVIV, Israel and RALEIGH, N.C. , Aug. 16, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.
One of today's biggest movers in the biotech sector is RedHill Biopharma (NASDAQ: RDHL ), a little-known specialty player in the space focusing on gastrointestinal and infectious diseases. Today, RDHL stock is up more than 75% in early afternoon trading on an announcement from the company that it has seen positive results for a key Phase 3 study.
Newly published in the peer-reviewed journal Antibiotics, the 331-patient Phase 3 Crohn's disease study data shows the primary endpoint of clinical remission at week 26 was achieved, with high statistical significance, in 36.7% (61/166) of orally administered RHB-104 plus standard of care (SoC) patients, compared to 22.4% (37/165) of placebo plus SoC patients (p=0.0048); Safety profile similar to placebo. Study conducted across more than 100 sites The advanced stage clinical data demonstrating the potential efficacy of oral RHB-104 triple antimicrobial therapy targeting Mycobacterium avium subspecies paratuberculosis (MAP,) supports the paradigm-changing hypothesis of a Mycobacterial basis to Crohn's disease, where high unmet medical need exists "This ground-breaking data shows that RHB-104, which contains antimicrobial therapy directed against Mycobacterium paratuberculosis, or MAP, which typically infects cattle, appears to be effective for the treatment of Crohn's disease - potentia
TEL-AVIV, Israel and RALEIGH, NC , July 22, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the "Agreement").
TEL-AVIV, Israel and RALEIGH, NC , July 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the mutual decision with Cosmo Technologies Ltd.
New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response [1] . Provides protection for opaganib's potential use in combination with a range of approved and in-development (ICIs) across a growing range of indications [2] through 2040 ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab) [3] Opaganib, a host-directed and potentially broad acting twice-daily oral, small molecule with a demonstrated safety & efficacy profile, is in development for multiple oncology, viral and inflammatory indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard