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.
RedHill Biopharma Ltd. files foreign-issuer reports that document its specialty biopharmaceutical business, ADS capital structure and corporate governance. Recent Form 6-K reports incorporate press releases and meeting materials covering Talicia commercialization, RHB-204, RHB-102 and opaganib development disclosures, and clinical or regulatory updates tied to gastrointestinal, infectious-disease and oncology programs.
The company’s SEC record also includes shareholder-meeting notices and voting results for restricted share unit grants and authorized share-capital changes, as well as Nasdaq listing-compliance communications for its American depositary shares. Incorporation-by-reference language links these current reports to Form S-8 equity compensation registrations and Form F-3 shelf registration statements, reflecting recurring disclosure topics around financing capacity, equity plans, governance and material events.
RedHill Biopharma reports that the FDA has granted rare pediatric disease designation to its investigational drug opaganib for treating neuroblastoma, a cancer that mainly affects babies and young children. This comes on top of opaganib’s existing orphan drug designation for neuroblastoma.
The new status can make opaganib eligible for a Priority Review Voucher, as well as potential benefits such as faster review, PDUFA fee waivers, tax credits and up to seven years of U.S. market exclusivity if the drug is approved. Preclinical data presented at AACR 2026 showed positive effects of opaganib as an add-on therapy in models of high‑risk neuroblastoma and triple‑negative breast cancer.
Opaganib is a novel, oral sphingosine kinase‑2 selective inhibitor being developed for multiple oncology, viral, inflammatory, metabolic and obesity‑related indications, alongside RedHill’s broader late‑stage pipeline and its commercial gastrointestinal drug Talicia.
RedHill Biopharma reports that it has launched recognition and enforcement proceedings in Korea to collect on a New York Supreme Court final judgment against Kukbo Co. Ltd totaling approximately $10.9 million. The judgment combines a main award of about $8.9 million and roughly $1.95 million for legal fees and expenses, each including accrued 9% statutory interest, which continues to build. The court’s principal award became final in November 2025, and the fee award became final after Kukbo failed to perfect its appeal by the March 2026 deadline, leaving no further appeals available. RedHill has previously obtained a Korean court attachment to help prevent Kukbo from disposing of assets, but it cautions there is no assurance on the timing or amount of any eventual recovery.
RedHill Biopharma reports it is actively discussing potential collaborations to advance its investigational oral drug opaganib for Ebola virus disease, including with the World Health Organization’s SOLIDARITY CORE clinical trial platform and other pharma partners. Opaganib is a host-directed, small molecule SPHK2 inhibitor with antiviral and anti-inflammatory properties in advanced clinical development.
The company highlights preclinical data suggesting filovirus-class activity and a dual mechanism that may block key viral entry pathways and modulate immune dysfunction. In a Phase 3 severe COVID-19 trial, opaganib add-on therapy showed a 70.2% mortality reduction in a remdesivir plus corticosteroids subgroup. RedHill notes more than 470 participants have been exposed to opaganib across studies and expanded access, and that the drug has FDA Orphan Drug designation for neuroblastoma and cholangiocarcinoma and is being studied in an 80-patient Phase 2 prostate cancer trial.
The company emphasizes that opaganib remains an investigational drug, has not been approved by any regulatory authority, and that inclusion in WHO or other Ebola programs is not guaranteed. Extensive forward-looking statement language underlines significant clinical, regulatory, funding and commercial risks across RedHill’s pipeline.
RedHill Biopharma Ltd. reports that it has filed a prospectus supplement dated May 7, 2026 to increase the maximum aggregate offering amount available under its existing at-the-market equity program. The program covers American Depositary Shares, with each ADS representing 10,000 ordinary shares.
The ADSs may be issued and sold from time to time under an At The Market Offering Agreement with H.C. Wainwright & Co., LLC originally dated February 3, 2025. The report also notes that related legal opinions and consents are filed as exhibits and that this update is incorporated by reference into multiple existing S-8 and F-3 registration statements.
RedHill Biopharma Ltd. supplements its Form F-3 prospectus to increase the maximum aggregate offering price available under its At The Market Offering Agreement with H.C. Wainwright & Co., LLC by $1,587,708. This addition is subject to the $1,854,911 limit imposed by General Instruction I.B.5 of Form F-3 and follows prior sales of 92,458 ADSs for aggregate gross proceeds of $267,204. The company reports a public float market value of $5,564,735.58 based on 51,052,621,000 ordinary shares held by non-affiliates (equivalent to 5,105,262 ADSs at $1.09 per ADS as of April 30, 2026). The ADSs trade on Nasdaq under the symbol RDHL.
RedHill Biopharma Ltd. files a post-effective amendment registering 6,465,559 ADSs for resale by YA II PN, LTD.
The prospectus covers resale of ADSs issued or issuable to YA under a Standby Equity Purchase Agreement, including up to 5,000,000 Advance Shares and other initial and commitment shares; the Company will not receive proceeds from YA resales.
RedHill Biopharma reported new in vitro results showing its investigational oral therapy RHB-204 has Mycobacterium avium subspecies paratuberculosis (MAP) killing efficacy comparable to predecessor RHB-104. The effect was achieved using lower doses of two active ingredients, suggesting potential for reduced toxicity and side effects.
RHB-204 targets MAP-positive Crohn’s disease and is supported by prior Phase 3 data from RHB-104, where RHB-104 plus standard of care achieved clinical remission at week 26 in 36.7% of patients versus 22.4% with standard of care alone, a 64% relative improvement. RHB-204 is patent protected through 2041 and benefits from FDA Fast Track, Orphan Drug and QIDP designations, as well as EU Orphan Designation for certain NTM disease, while a novel Phase 2 study in a specifically defined MAP-positive Crohn’s population is planned with a focus on non-dilutive funding.
RedHill Biopharma’s 2025 annual report highlights severe liquidity pressure and a going concern warning. Net cash used in operating activities was $9.7 million in 2025, leaving cash, cash equivalents, short‑term investments and restricted cash of only $4.1 million as of December 31, 2025, which management states is insufficient to fund operations and obligations for the next year.
The company still carries legacy Movantik® liabilities of about $1.5 million and obligations of $5.7 million under the Global Termination Agreement, alongside other overdue payables. RedHill depends on raising significant additional capital and negotiating deferred payments to continue operating, while commercialization prospects now rely heavily on Talicia® via Talicia Holdings and its collaboration with Cumberland.
Management also reports that internal control over financial reporting remained ineffective as of December 31, 2025 due to an unresolved material weakness affecting allowance for deductions from revenues, raising continued reporting and governance risk.
RedHill Biopharma reported 2025 results marked by a reshaped Talicia business, new partnerships and a small overall loss. On a continuing basis, revenue was $0.3 million, with an operating loss of $7.9 million and net loss from continuing operations of $8.1 million.
Talicia commercial operations moved into Talicia Holdings Inc., a 70%-owned joint venture with Cumberland, which generated discontinued-operation net income of $7.7 million. A licensing deal with Hyloris for RHB‑102 (Bekinda) carries up to $60 million in potential milestones plus royalties.
Total assets rose to $25.3 million and equity improved to $4.3 million, while year-end cash was $4.1 million after $9.7 million of operating cash use, partly offset by $7.3 million from equity financing. The company also secured a $10.5 million final court judgment against Kukbo, not yet reflected as a receivable, and advanced multiple late-stage GI and oncology programs.