Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on the U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. According to multiple company disclosures and SEC-filed press releases, RedHill promotes the FDA-approved gastrointestinal drug Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults and advances a late-stage pipeline that includes several oral therapeutic candidates targeting significant unmet medical needs.

Core commercial product: Talicia®

RedHill’s commercial portfolio centers on Talicia, described in company press releases and Form 6-K filings as a novel, fixed-dose, all-in-one oral capsule that combines two antibiotics (amoxicillin and rifabutin) with a proton pump inhibitor (omeprazole). Talicia is indicated for the treatment of H. pylori infection in adults and has received a Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration, which provides eligibility for a total of eight years of U.S. market exclusivity. Company materials state that Talicia is patent protected through 2042 and is also approved by the United Arab Emirates Ministry of Health.

RedHill’s disclosures highlight that Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori antibiotic resistance and that it has been listed as a first-line treatment option for H. pylori infection in the American College of Gastroenterology (ACG) Clinical Guideline. In press releases, RedHill also notes that Talicia is the number one branded H. pylori therapy prescribed by U.S. gastroenterologists and refers to it as a leading first-line therapy in that setting. The company emphasizes the medical context that H. pylori is classified by the World Health Organization as a Group 1 carcinogen and is a key risk factor for gastric cancer, peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma.

RedHill has reported multiple licensing and co-commercialization arrangements around Talicia. A 2025 press release and accompanying Form 6-K describe a U.S. co-commercialization agreement and strategic partnership with Cumberland Pharmaceuticals Inc., under which Cumberland invests capital, assumes responsibility for distribution, and shares net revenues and operational responsibilities for Talicia in the United States. Separate filings describe ex-U.S. licensing deals, including a Middle East agreement with guaranteed payments, milestones and tiered royalties, and the first ex-U.S. commercial launch of Talicia generating milestone and royalty payments to RedHill.

Late-stage development pipeline

Beyond Talicia, RedHill’s SEC filings and press releases describe several key clinical late-stage development programs:

• Opaganib (ABC294640) – A proprietary, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor characterized by the company as having anti-inflammatory, antiviral and anticancer activity. RedHill reports that opaganib is targeted at multiple potential oncology, radioprotection, viral, inflammatory and gastrointestinal indications, including gastrointestinal acute radiation syndrome (GI-ARS), hospitalized COVID-19, and advanced prostate cancer in combination with darolutamide. Company communications also note orphan-drug designations in cholangiocarcinoma and neuroblastoma, preclinical activity in several cancers and viral diseases, and selection for evaluation in U.S. government medical countermeasure and pandemic preparedness programs.
• RHB-102 (Bekinda®) – A proprietary, once-daily, bimodal extended-release oral tablet formulation of ondansetron, a 5-HT3 antagonist. RedHill describes RHB-102 as targeting GLP-1/GIP receptor agonist therapy-associated gastrointestinal intolerance (including nausea, vomiting and diarrhea), oncology support for chemotherapy- and radiotherapy-induced nausea and vomiting (CINV/RINV), acute gastroenteritis and gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D). Company news reports positive results from a U.S. Phase 3 study in acute gastroenteritis and gastritis and a U.S. Phase 2 study in IBS-D, as well as a positive comparative pharmacokinetic study in an oncology-support program. RedHill states that RHB-102 is being developed via the FDA 505(b)(2) route and is partnered with Hyloris Pharma for worldwide development and commercialization outside North America.
• RHB-204 – Described as a next-generation optimized formulation of RHB-104. Company disclosures indicate a planned Phase 2 study for Crohn’s disease, based on positive Phase 3 Crohn’s disease study results with RHB-104, and a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
• RHB-107 (upamostat) – An oral broad-acting, host-directed serine protease inhibitor that RedHill associates with pandemic preparedness. Filings and press releases describe RHB-107 as in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and as targeting multiple other cancer and inflammatory gastrointestinal diseases.

Therapeutic focus and scientific positioning

RedHill’s public communications consistently describe the company as focusing on oral therapies that address significant burdens in gastrointestinal and infectious diseases and selected oncology indications. The company emphasizes mechanisms such as SPHK2 inhibition for opaganib and host-directed serine protease inhibition for RHB-107, as well as extended-release 5-HT3 antagonism for RHB-102. These programs are positioned by RedHill as relevant to areas such as chronic lymphocytic leukemia resistance management (in combination with venetoclax), advanced prostate cancer, hospitalized and non-hospitalized COVID-19, and GI complications related to radiation, chemical exposure and GLP-1/GIP receptor agonist therapies.

In multiple SEC Form 6-K filings, RedHill notes collaborations with U.S. government and academic partners for opaganib’s development as a medical countermeasure, including programs led by the Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). The company also reports preclinical and clinical data for opaganib in viral infections, including SARS-CoV-2 and Ebola, and in oncology settings.

Geographic footprint and listing status

RedHill Biopharma Ltd. is an Israeli company with its address in Tel Aviv, Israel, as reflected in its Form 6-K filings. The company’s American Depositary Shares (ADSs), each representing ordinary shares, trade on the Nasdaq Capital Market under the ticker RDHL. Recent filings describe interactions with Nasdaq regarding the minimum stockholders’ equity requirement under Listing Rule 5550(b)(1), including a Staff Determination notification, an appeal process, and a subsequent Nasdaq confirmation that RedHill had regained compliance with the stockholders’ equity requirement.

Capital markets and corporate actions

RedHill’s SEC filings detail various capital-raising and financing arrangements, including an at-the-market (ATM) offering program and an Any Market Purchase Agreement with Alumni Capital LP for the sale of American Depositary Shares, subject to ownership limits. The company has filed multiple registration statements on Forms F-3 and S-8, and has amended its purchase agreement with Alumni Capital to adjust beneficial ownership thresholds for certain types of purchase notices.

In addition, RedHill has reported legal proceedings and judgments that are relevant to its financial position. A series of Form 6-K filings describe New York Supreme Court summary judgment awards and subsequent appellate decisions in favor of RedHill in a dispute with Kukbo Co. Ltd., including monetary awards for principal amounts and legal costs and expenses, plus statutory interest. The company has also disclosed a Korean court attachment grant against Kukbo’s assets in connection with enforcement of these judgments.

Partnerships and ex-U.S. commercialization

RedHill’s strategy, as described in its press releases and SEC filings, includes partnering and out-licensing to expand the reach of its assets and generate non-dilutive revenue streams. Examples include:

• A co-commercialization partnership with Cumberland Pharmaceuticals for Talicia in the United States, involving shared net revenues and joint operational responsibility across sales, marketing, manufacturing, supply, regulatory and administrative functions.
• Licensing agreements for Talicia in the Middle East, with guaranteed payments, milestones and tiered royalties, intended to accelerate Talicia’s entry into additional markets in that region.
• A global partnership with Hyloris Pharma for RHB-102 outside North America, under which Hyloris is responsible for worldwide development and commercialization in those territories.

Regulatory and clinical disclosure practices

As a foreign private issuer, RedHill reports to the U.S. Securities and Exchange Commission primarily through Form 20-F annual reports and Form 6-K current reports. Many of the company’s scientific and clinical updates, partnership announcements, and legal developments are furnished on Form 6-K and explicitly incorporated by reference into its existing registration statements. These filings often include detailed descriptions of clinical trial designs, endpoints, preclinical data, and regulatory strategies for opaganib, RHB-102, RHB-204 and RHB-107, along with risk factor discussions related to development, commercialization, funding and regulatory approvals.

Investment and risk considerations

RedHill’s press releases and SEC filings include extensive forward-looking statements and risk disclosures. The company highlights uncertainties related to clinical trial success, regulatory feedback, government funding, commercialization of its products, maintenance of Nasdaq listing requirements, execution of licensing and co-commercialization transactions, intellectual property protection and competitive dynamics. Investors reviewing RDHL stock typically consider these disclosures, along with the company’s focus on gastrointestinal, infectious disease and oncology markets, its reliance on Talicia revenues, and the progress of its late-stage pipeline programs.

Summary

In summary, RedHill Biopharma Ltd. is a Nasdaq-listed, Israel-based specialty biopharmaceutical company with a clear emphasis on gastrointestinal and infectious disease therapeutics and selected oncology indications. Its business combines the commercial promotion of Talicia for H. pylori infection with the clinical development of oral drug candidates such as opaganib, RHB-102, RHB-204 and RHB-107. Company filings underscore a strategy that integrates U.S.-focused development and commercialization with ex-U.S. partnerships, government collaborations for medical countermeasures, and active capital markets participation.