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TEL-AVIV, Israel and RALEIGH, N.C. - RedHill Biopharma Ltd. (NASDAQ: NASDAQ:RDHL), a specialty biopharmaceutical company with a market capitalization of $7.53 million, today announced the initiation of a Phase 2 clinical study evaluating the efficacy of opaganib in combination with darolutamide in treating metastatic castrate-resistant prostate cancer (mCRPC). According to InvestingPro analysis, the company appears undervalued despite facing financial challenges, with a weak overall Financial Health Score of 1.51. The study is backed by Bayer (OTC:BAYRY) (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 trial will enroll 80 patients and aims to determine if opaganib can enhance the effectiveness of darolutamide, a treatment for prostate cancer which often develops resistance to standard care. The primary measure of success will be the improvement in 12-month radiographic progression-free survival (rPFS). A companion lipid biomarker test, PCPro, will be used to identify patients who are likely to have a poor prognosis and may benefit from the combined treatment approach.
Prostate cancer is the world’s second most diagnosed cancer, with approximately 1.5 million new cases annually, leading to nearly 400,000 deaths. The market for prostate cancer treatments was valued at around $12 billion in 2023. RedHill’s current revenue stands at $3.71 million, with InvestingPro data showing analysts anticipate significant sales growth this year. Discover 12 more exclusive insights about RedHill’s financial performance with an InvestingPro subscription. Opaganib, developed by RedHill, is a novel, orally administered small molecule with potential applications across oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection indications.
Professor Horvath highlighted the uniqueness of the therapeutic combination and the PCPro biomarker in metabolic targeting for metastatic prostate cancer. She pointed out that prior research indicates opaganib may enhance the efficacy of androgen receptor signaling inhibitor treatments in vitro.
Dr. Mark Levitt, RedHill’s Chief Scientific Officer, stressed the limited treatment options for men with mCRPC and noted the significance of darolutamide in treating prostate cancer. If opaganib proves to reduce resistance to darolutamide therapy, it could mark a substantial advancement in managing advanced treatment-resistant mCRPC.
The study is a double-blind, placebo-controlled randomized trial, with patients who have not received treatment with newer potent AR signaling inhibitors. Eligible patients will be randomized to receive either darolutamide with a placebo or darolutamide with opaganib, with treatment starting within seven days of randomization.
This news is based on a press release statement from RedHill Biopharma Ltd. For comprehensive analysis of biotech companies and their clinical trials, including advanced financial metrics and Fair Value estimates, visit InvestingPro. The platform offers exclusive insights into company health scores, valuation metrics, and future growth potential.
In other recent news, RedHill Biopharma Ltd. has made several noteworthy advancements. The company’s H. pylori treatment, Talicia, has expanded its coverage under Humana (NYSE:HUM)’s Part D Plan, providing access to over eight million additional Medicare lives. This development aligns with the updated American College of Gastroenterology Clinical Guideline, which recommends Talicia as a preferred first-line treatment for H. pylori infection, a condition affecting approximately 35% of the U.S. adult population.
RedHill has also been awarded a judgment of approximately $8 million plus costs by the New York Supreme Court in a legal case against South Korea-based Kukbo Co. Ltd. This judgment includes $6.5 million plus about $1.5 million in interest, concluding a dispute over Kukbo’s failure to fulfill payment obligations under a Subscription Agreement and an Exclusive License Agreement with RedHill.
In addition, the U.S. Biomedical Advanced Research and Development Authority has selected RedHill’s opaganib for development funding as a potential Ebola virus disease treatment. This funding supports opaganib’s development under the Animal Rule pathway, which allows for animal model efficacy studies to support FDA approval when human trials are not feasible.
Furthermore, RedHill has renewed its contract with Medi-Cal, ensuring continued access to Talicia for approximately 15 million Californians. Lastly, RedHill Biopharma has finalized a Global Termination Agreement, augmenting its cash position by approximately $9.9 million and potentially granting access to an additional $0.74 million. These are all recent developments that highlight RedHill’s continued commitment to enhancing patient outcomes and financial stability.
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