Welcome to our dedicated page for Redhill Biopharm SEC filings (Ticker: RDHL), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The RedHill Biopharma Ltd. (Nasdaq: RDHL) SEC filings page on Stock Titan provides centralized access to the company’s Form 20-F annual reports and Form 6-K current reports, which together document its regulatory, clinical, commercial and financing activities. As a foreign private issuer focused on gastrointestinal diseases, infectious diseases and oncology, RedHill uses Form 6-K extensively to furnish press releases and other information to the U.S. Securities and Exchange Commission.
In these filings, investors can review detailed disclosures about Talicia®, RedHill’s FDA-approved oral therapy for Helicobacter pylori infection in adults, including its indication, QIDP-based market exclusivity, patent coverage and ex-U.S. licensing arrangements. Filings also describe the company’s late-stage development programs: opaganib (ABC294640), a sphingosine kinase-2 selective inhibitor with anticancer, anti-inflammatory and antiviral activity; RHB-102 (Bekinda®), an extended-release ondansetron formulation for multiple gastrointestinal and oncology-support indications; RHB-204, an optimized formulation of RHB-104 for Crohn’s disease and pulmonary nontuberculous mycobacteria disease; and RHB-107 (upamostat), a host-directed serine protease inhibitor in late-stage development for non-hospitalized symptomatic COVID-19 and other conditions.
RedHill’s Form 6-K reports also cover capital markets and financing transactions, such as at-the-market offering programs, purchase agreements for American Depositary Shares, and amendments to ownership thresholds. Additional filings document Nasdaq listing compliance matters, including notifications related to the minimum stockholders’ equity requirement and subsequent confirmation of regained compliance, as well as legal proceedings like New York Supreme Court judgments and Korean court attachment orders in the Kukbo dispute.
Stock Titan’s interface is designed to surface these filings as they are furnished to EDGAR and to pair them with AI-powered summaries that explain the key points of lengthy documents. Users can quickly identify items such as quarterly and interim financial information, registration statement incorporations by reference, and governance or financing updates, while drilling down into full-text filings when more detail is needed.
RedHill Biopharma Ltd. filed a Form 6-K attaching a press release that reports a New York Supreme Court appeal decision upholding a $10 million summary judgment in the company’s favor against Kukbo. The filing reiterates RedHill’s corporate registration details and lists recent and prior registration statements incorporated by reference. The document also summarizes RedHill’s clinical-stage pipeline, including opaganib (ABC294640) (multiple indications including GI-ARS, hospitalized COVID-19, prostate cancer), RHB-204 (planned Phase 2 for Crohn’s disease; Phase 3-stage for pulmonary NTM), RHB-107 (upamostat) (late-stage for non-hospitalized COVID-19 and other indications), and RHB-102 (positive Phase 2/3 results for GI indications; partnered with Hyloris Pharma). The filing contains no financial results or quantified impact of the judgment.
RedHill Biopharma Ltd. announced that the New York Supreme Court awarded the company approximately $1.82 million in legal costs and expenses, in addition to a prior summary judgment award of approximately $8.25 million, with a 9% ongoing statutory interest applicable to both awards. The company also obtained a court-ordered attachment from Korea's Incheon District Court to seize Kukbo Co. Ltd.'s assets pending enforcement. Kukbo appealed the summary judgment on December 4, 2024, and briefing on that appeal is complete with oral argument tentatively scheduled for the September term; Kukbo may also appeal the legal-costs award. The release reiterates RedHill's clinical and commercial programs and includes standard forward-looking risk disclosures.
RedHill Biopharma reported receipt of its first ex-U.S. Talicia sales milestone, royalties and other payments totaling approximately $1.1 million following Talicia's first commercial launch outside the U.S. in 2024. Talicia is an FDA-approved, rifabutin-based therapy for H. pylori, a common infection affecting over 50% of adults worldwide and a major risk factor for gastric cancer and peptic ulcers. The product has QIDP designation providing up to eight years of U.S. exclusivity and patent protection through 2042. RedHill said Talicia showed up to 90% eradication in adherent patients in Phase 3 and contrasted this with lower effectiveness of clarithromycin-based regimens.
RedHill Biopharma disclosed it is not in compliance with Nasdaq Listing Rule 5550(b), which requires minimum stockholders' equity of $2,500,000. Nasdaq notified the Company of the deficiency on April 15, 2025 and on August 8, 2025 granted an extension giving the Company until October 13, 2025 to regain compliance.
The Company has submitted a plan to Nasdaq to restore compliance; if it does not meet the requirement by the extension date it may appeal to a Hearings Panel for additional time. The filing also notes that forward-looking statements about achieving compliance depend on market conditions and the satisfaction and closing of financing arrangements referenced in other filings.
RedHill Biopharma (Nasdaq: RDHL) filed a Form 6-K announcing positive FDA Type C meeting feedback for RHB-204, its next-generation, orally administered triple-antibiotic for Crohn’s disease (CD). The Agency agreed to a first-ever Phase 2 trial in MAP-positive CD patients, with co-primary endpoints of mucosal remission and MAP eradication. Use of rapid MAP diagnostics from two academic partners allows a smaller sample size, meaning lower cost and faster completion.
RHB-204 is protected by patents to 2041 and leverages Phase 3 data from predecessor RHB-104 that showed a 64 % efficacy improvement versus standard of care. Management plans to fund the study through non-dilutive grants/partnerships and pursue additional FDA designations (orphan, breakthrough, fast track) that could confer exclusivity and priority review vouchers. The Crohn’s market is forecast to expand from $13.6 bn in 2024 to $19 bn in 2033, creating significant commercial upside if the program succeeds. Key risks remain: trial execution, securing external funding, and eventual regulatory approval.
FAQ
What is the current stock price of Redhill Biopharm (RDHL)?
What is the market cap of Redhill Biopharm (RDHL)?
