Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma (NASDAQ:RDHL) has secured an additional $1.82 million award for legal costs and expenses from the New York Supreme Court, supplementing its previous $8.25 million summary judgment victory against Kukbo Co. Ltd. Both awards include a 9% ongoing statutory interest accrual.

The company has also obtained an attachment grant from Korea's Incheon District Court against Kukbo, enabling court-ordered seizure of Kukbo's assets to prevent disposal before judgment enforcement. While Kukbo has appealed the summary judgment decision, with oral arguments scheduled for September, they retain the right to appeal the latest legal costs award.

RedHill Biopharma (NASDAQ:RDHL) has received its first ex-U.S. sales milestone payment, royalties, and other payments for Talicia, totaling $1.1 million. Talicia, the first FDA-approved rifabutin-based therapy for H. pylori infection, is currently the leading branded first-line treatment prescribed by U.S. gastroenterologists.

The drug maintains strong market protection through FDA's QIDP designation, providing 8 years of market exclusivity, with patent protection extending through 2042. Clinical data shows Talicia achieved up to 90% eradication rate in adherent patients, significantly outperforming traditional clarithromycin-based therapies which showed only 68.5% effectiveness, dropping to 32% in resistant cases.

RedHill Biopharma (NASDAQ:RDHL) has received positive FDA feedback for its groundbreaking RHB-204 Crohn's disease treatment program. The FDA guidance enables a novel Phase 2 study targeting Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease patients - the first of its kind.

RHB-204, patent-protected until 2041, is an optimized formulation of RHB-104, which demonstrated 64% improved efficacy in Phase 3 trials. The drug features a 40% reduced pill burden and enhanced tolerability. The company has established collaborations with academic centers for advanced MAP detection diagnostics, addressing a previous major development barrier.

The Crohn's disease market is projected to grow from $13.6 billion in 2024 to over $19 billion by 2033. The company expects non-dilutive funding for the program and anticipates benefits including pediatric orphan drug designation transfer and potential breakthrough therapy status.

RedHill Biopharma (NASDAQ: RDHL) has initiated patient recruitment for a Phase 2 study evaluating opaganib in combination with darolutamide for treating metastatic castrate-resistant prostate cancer (mCRPC). The study, sponsored by ANZUP and supported by Bayer and Ramsay Hospital Research Foundation, will be conducted across 10 sites in Australia and New Zealand.

The 60-participant placebo-controlled randomized study will utilize the PCPro™ lipid biomarker test to identify poor-prognosis patients who may benefit from the combination therapy. The study's primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Professor Lisa Horvath from Sydney's Chris O'Brien Lifehouse will lead the research.

The study aims to address prostate cancer, which is the second most diagnosed cancer globally with approximately 1.5 million new cases and 400,000 deaths annually. The global prostate cancer market is valued at approximately $12 billion.

RedHill Biopharma (NASDAQ: RDHL) has secured a significant legal victory in its ongoing dispute with Kukbo Co. Ltd. The Incheon District Court in Korea has granted an asset freeze on Kukbo's assets, following RedHill's successful $8.25 million plus legal fees summary judgment win in the New York Supreme Court.

The judgment stems from Kukbo's failure to honor subscription and licensing agreements signed in October 2021 and March 2022. The total amount includes $1.75 million in accrued interest at 9%. While Kukbo filed a notice of appeal on December 4, 2024, they have until June 4, 2025, to perfect their appeal, subject to potential extension. The New York Supreme Court has dismissed all of Kukbo's counterclaims.

RedHill Biopharma (NASDAQ: RDHL) announces support for a new Medscape H. Pylori CME program aimed at advancing clinical knowledge and improving patient outcomes. The program consists of two parts: a livestreamed event on May 6, 2025, led by experts William Chey, MD, Vivian Asamoah, MD, and Shailja Shah, MD, MPH, followed by an expert roundtable in June 2025. The educational initiative focuses on H. pylori management, antibiotic resistance, and guideline-directed therapies. The company highlights that their product Talicia® is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address antibiotic resistance. RedHill also announces plans to submit a Marketing Authorisation Application for Talicia in the UK.

RedHill Biopharma (RDHL) has secured a key Chinese patent for RHB-107, its COVID-19 treatment candidate. The patent, granted by China National Intellectual Property Administration, covers the compound's molecular structure and its use in treating SARS-CoV-2 infections, including variants.

The company's Phase 2 study demonstrated promising results with 100% reduction in COVID-19 hospitalization (0/41 patients on RHB-107 vs 3/20 on placebo) and approximately 88% reduction in new severe COVID-19 symptoms (2.4% RHB-107 vs 20% placebo). Recovery time was notably faster at 3 days with RHB-107 compared to 8 days with placebo.

RHB-107 is an oral, once-daily, host-directed antiviral designed to act independently of viral spike protein mutations. The patent strengthens RedHill's position in the global COVID-19 therapeutic market, projected to be worth over $3 billion in 2025.

RedHill Biopharma (Nasdaq: RDHL) has received a notification from Nasdaq on April 15, 2025, indicating non-compliance with the minimum stockholders' equity requirement for continued listing. The company reported a stockholders' deficit of $4,683,000 in its 2024 Annual Report, falling below Nasdaq's required minimum of $2,500,000 in stockholders' equity.

The notification does not immediately affect RedHill's listing on the Nasdaq Capital Market or its business operations. The company has until May 30, 2025 (45 calendar days) to submit a compliance plan. If accepted, Nasdaq may grant up to 180 calendar days from the notification date to demonstrate compliance.

RedHill Biopharma (RDHL) has published positive data for opaganib in the treatment of obesity and diabetes, showing efficacy comparable to semaglutide in preclinical models. The study, published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrates that opaganib effectively suppresses weight gain and improves glucose tolerance in high-fat diet mice.

As a first-in-class oral, non-peptide therapeutic targeting sphingosine kinase-2 (SPHK2), opaganib offers potential advantages over current GLP-1 inhibitors, potentially avoiding their common side effects and administration challenges. The drug has already shown safety and tolerability data in over 470 subjects across several clinical programs.

The company is positioning opaganib as a potential disruptor in the global obesity-diabetes drugs market, which is projected to reach $100 billion by 2034. This market is currently dominated by GLP-1 inhibitors like Novo Nordisk's Ozempic and Wegovy, and Eli Lilly's Trulicity, Zepbound, and Mounjaro.