RedHill Biopharma (RDHL) News & Sentiment

The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on path to FDA approval, with FDA guidance expected in Q2/25 -- Patent protected until 2041, RHB-204 is a next generation anti-MAP therapy derivative of RHB-104 3  which successfully met its groundbreaking Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus SoC and showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes -- Based on insights from RHB-104's statistically significant positive Phase 3 study results, the improved formulation RHB-204 is designed to reduce pill burden and further enhance tolerability, safety and adherence, and along with the uniquely defined patient population (MAP-positive), allows for a study design with a small sample size and decisive endpoints, entailing lower study costs and expedited timeframe -- The role of MAP as a cause of CD, to be tested in this study, supports a paradigm-shifting new therapeutic approach for CD – focused on addressing the actual cause of the disease, not the symptoms -- The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033, presenting significant commercial potential for a new FDA approved therapy RALEIGH, N.C.

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 agreements TEL-AVIV, Israel and RALEIGH, N.C. , Dec. 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

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 selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA -- The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs).

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 eradication without needing prior resistance testing Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists [2] for H.

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 analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60%, also indicates that FiO2 of greater than 60% may represent a threshold level for disease severity, and may potentially be a patient selection biomarker, an important finding for future therapeutic strategies and studies With 30,000 Americans dead due to COVID-19 so far this year according to the World health Organization[1], new, effective and safe therapies are still very much needed 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 in oncology indications, viral infection, nuclear/radioprotection and other inflammatory diseases TEL AVIV, Israel and RALEIGH, N.C., Sept. 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

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, advancing and largely financially de-risked pipeline via U.S. government and other collaborations Addressing substantial and underserved indications : In oncology viral pandemic preparedness, nuclear/radioprotection, and obesity/diabetes Building value : In the lab and in the clinic through new studies, generating new intellectual property and publications and forging the right partnerships for our assets Streamlined U.S. commercial organization : Cost reduction measures resulted in a much smaller, more efficient and cost-effective organization while still maintaining a leadership position with Talicia ® R&D and Commercial Highlights : Opaganib: - U.S. Army program for Ebola (believed to  be the first host-directed molecule to show activity in vivo in Ebola virus disease)- Orphan drug designation granted by FDA for neuroblastoma  - Discussions ongoing for a potential externally-funded, mid-stage clinical study in an additional underserved oncology indication  - U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure  - Positive in vivo study results support potential of opaganib therapy in diabetes / obesity RHB-107: -  COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment; enrollment estimated to be completed in the first half of 2025 - U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir RHB-104 : Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team: - Expected upcoming new H.

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.

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.