RedHill Biopharma

RedHill Biopharma Ltd. develops medicines for gastrointestinal and infectious diseases. It operates through Commercial Operations, and the Research and Development segments. The Commercial Operations segment covers all areas relating to the commercial sales and is being performed by the subsidiary in the U.S. The Research and Development segment includes the study and licensing of therapeutic candidates. Its products include Talicia, Movantik, and Aemcolo. The company was founded by Dror Ben-Asher and Ori Shilo on August 3, 2009 and is headquartered in Tel Aviv, Israel.

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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 gastrointestinal acute radiation syndrome (GI-ARS) Positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirm opaganib's protective activity Discussions now ongoing with the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID), which leads the RNCP, regarding plans for the next phase of development along the U.S. Food and Drug Administration's (FDA) Animal Rule pathway to approval TEL AVIV, Israel and RALEIGH, N.C. , Dec. 10, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development

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 Biopharma Awarded Judgment of Approximately $8 Million Plus Costs by New York Supreme Court

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).

RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND

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 development under the FDA's Animal Rule pathway to approval Used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is today widely used in industrial processes for the manufacture of plastics and pesticides.

RedHill Announces Collaboration with a Leading U.S. Academic Medical Center to Develop Opaganib as a Countermeasure Against Phosgene Inhalation Injury

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 approval as an MCM for EBOV -- Recent U.S. Army-funded studies showed that opaganib delivered a statistically significant increase in survival in an in vivo EBOV model. The BARDA research and development contract provides initial funding for the collaboration, in pursuit of advancing opaganib to mitigate infection and contain EBOV outbreaks -- This year marks the 10th anniversary of the West Africa Ebola epidemic in which 11,000 people died, and there is still an urgent need for effective and useable therapies, with EBOV proving fatal in around half of all cases according to the World Health Organization (WHO) 1 -- Opaganib, a novel potentially broad-acting drug, has shown mutation-resistant antiviral and anti-inflammatory activity, likely to directly impact vascular health - one of the main targets for EBOV dysfunction.

RedHill Biopharma Secures U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment

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 -- The renewed terms reflect both parties' ongoing commitment to improving patient access and outcomes, reinforcing Talicia's role as an essential treatment option, and follow the new American College of Gastroenterology (ACG) Clinical Guideline 1  for H. pylori infection, listing 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 H.

RedHill and Medi-Cal Deal Maintains Talicia® Reimbursement Without Prior Authorization for 15 Million Californians

New U.S. patent issued covering the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO2)) 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% FiO2 levels had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134), including: increased number of patients no longer requiring supplemental oxygen by day 14 of opaganib treatment (76.9% vs. 63.4%; p-value =0.033), a 62.6% reduction in intubation/mechanical ventilation (6.84% vs.

RedHill Announces New U.S. Coronavirus Patent for Opaganib, Valid Through 2041

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.

RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines

TEL AVIV, Israel and RALEIGH, N.C. , Sept. 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

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.

New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality

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.

RedHill Biopharma Announces First Half 2024 Business Highlights

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 Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma

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.

Talicia® Launched in the United Arab Emirates

On Monday, RedHill Biopharma Ltd. RDHL released results from multiple  in vivo studies, undertaken by RedHill's partner, Apogee Biotechnology Corporation.

Israel-Based RedHill's Investigational COVID-19 Treatment Shows Encouraging Action In Obesity And Diabetes

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.

RedHill Announces Positive Obesity and Diabetes Results with Opaganib

TEL AVIV, Israel and RALEIGH, N.C. , Aug. 16, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Plan to Implement ADS Ratio Change

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.

Why Is RedHill Biopharma (RDHL) Stock Up 75% Today?

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 - potentially opening a new avenue of therapy directed against its possible cause," said Dr. David Y.

Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease

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").

RedHill Biopharma Strengthens Cash Balance, Settles Obligations and Removes Talicia® Lien

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.

RedHill Biopharma Terminates License Agreement for Aemcolo®

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 exposure TEL-AVIV, Israel and RALEIGH, N.C.

RedHill Announces a New Patent Covering Opaganib in Combination with Immune Checkpoint Inhibitors, Valid Through 2040

The new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) is valid through 2035 and adds to opaganib's strong global intellectual property portfolio across multiple indications -- U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability -- A host-directed and potentially broad acting twice-daily oral, small molecule, opaganib is in development for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure. It has a demonstrated safety and efficacy profile, and is well-suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute TEL-AVIV, Israel and RALEIGH, N.C.

RedHill Announces New Opaganib Chinese Patent Against Ebola Virus Valid Through 2035

First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat)1  for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense The study is expected to be completed by the end of 2024 RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study2 RHB-107 is a novel, oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations3 RALEIGH, N.C. and TEL-AVIV, Israel , April 24, 2024 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study

RedHill continues corporate transformation to focus on U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base   Focused externally funded R&D: Opaganib for nuclear and chemical medical countermeasure (NIH funding):  Selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. Nuclear and chemical incident response strategies are characterized by significant government stockpiling of approved agents Opaganib for Ebola (U.S. Army funding): U.S. Army studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability RHB-107 for COVID-19 (U.S. DoD funding): Selected for inclusion in the 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment; COVID-19 treatment continues to be a multi-hundreds of million-dollar market RHB-107 for Ebola (U.S. Army funding): RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir.

RedHill Biopharma Announces Full-Year 2023 Results and Operational Highlights

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

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