RDHL Stock Recent News

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 by Bayer (ETR: BAYN) and the Ramsay Hospital Research Foundation, and will be led by Professor Lisa Horvath from Chris O'Brien Lifehouse and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) The study will utilize a companion lipid biomarker test (PCPro [1] ) to select mCRPC patients who have a poor prognosis due to standard of care treatment and who may benefit from an opaganib + darolutamide combination treatment approach . Primary endpoint will be improved 12-month radiographic progression-free survival (rPFS) Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per yea

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) Clinical Guideline lists Talicia as a first-line option for treatment of H.

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

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.

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.

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, o

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 Commer

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.