Regorafenib

TEL AVIV, Israel, March 31, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission (the 'SEC'). The report is available on the SEC's website, at and Galmed's Investor Relations website, at . Shareholders can obtain copies of Galmed's Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Galmed's Investor Relations Department at [email protected]. About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development. Forward-Looking Statements Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivarga® and Metformin as a new fixed-dose combination treatment, the expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 31, 2026 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. Logo - SOURCE Galmed Pharmaceuticals Ltd. 21% more press release views with Request a Demo

Application submitted for manufacturing and marketing approval of ripretinib in Japan for the indication of “gastrointestinal stromal tumor that has progressed following cancer chemotherapy” Ripretinib has significantly prolonged the primary endpoint of progression-free survival compared to placebo in the INVICTUS study Already approved in the United States and Europe; recognized as a highly necessary medicine by the government review committee addressing drug loss in Japan Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) today announced that Ono submitted an application for the manufacturing and marketing approval of ripretinib (DCC-2618), developed by Deciphera Pharmaceuticals, Inc. (“Deciphera”), for the indication of “gastrointestinal stromal tumor that has progressed following cancer chemotherapy.” This application is based on the results of the INVICTUS study, a global Phase 3 clinical study, evaluating the efficacy of ripretinib compared to placebo in patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. In this study, ripretinib significantly prolonged the primary endpoint of progression-free survival (PFS) compared to placebo. “GIST is recognized as a rare disease worldwide, and ripretinib, developed by Deciphera, has already been approved in more than 40 countries and regions, including the United States and Europe. This application for approval of ripretinib represents a significant advancement for patients with GIST in Japan,” said Tatsuya Okamoto, Corporate Officer / Executive Director, Clinical Development of Ono. “Moving forward, we remain committed to developing and providing innovative medicines to meet the treatment needs of patients and the expectations of society.” “The application submission brings us one step closer to providing patients in Japan with advanced GIST a potential new treatment option. We anticipate that this submission may help address the issue of delayed access to new medicines, which remains a significant challenge for patients in Japan,” said Ryota Udagawa, President and Chief Executive Officer of Deciphera. “As GIST is a rare type of tumor, the limited availability of disease information and current treatment options are likely to cause significant anxiety for patients. Together with our group companies, we will continue to make every effort to deliver ripretinib to patients in Japan suffering from advanced GIST as quickly as possible.” The INVICTUS Phase 3 clinical study is a randomized, double-blind, placebo-controlled, international, multicenter study conducted in 12 overseas countries including US and EU to evaluate the safety, tolerability, and efficacy of ripretinib compared to placebo in 129 patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Patients were randomized 2:1 to either 150 mg of ripretinib or placebo once daily. In the INVICTUS study, ripretinib significantly prolonged the primary endpoint of PFS determined by independent central radiologic review (a median PFS of 6.3 months in ripretinib arm compared to 1.0 month in the placebo arm, HR of 0.15, p<0.0001). 1) GIST is a mesenchymal tumor that arises from the muscular layer of the gastrointestinal tract and forms a mass that pushes up the mucosa from below. GIST is a rare disease, with an incidence of approximately 1 to 2 cases per 100,000 population per year. In Japan, the number of patients diagnosed with GIST between 2016 and 2018 was 4,475 over three years (approximately 1,492 cases per year; crude incidence rate: 1.18 cases per 100,000 population). 2) It is known that mutations in KIT (KIT proto-oncogene receptor tyrosine kinase) and PDGFRα (platelet-derived growth factor receptor α) are involved in the development of the majority of patients with GIST. For unresectable, metastatic, or recurrent GIST, four agents—imatinib, sunitinib, regorafenib, and pimitespib—are currently approved in Japan. According to the Japanese clinical practice guidelines for GIST, these agents are recommended as first-line, second-line, third-line, and fourth-line treatments, respectively. 3) Ripretinib is an orally administered, tyrosine kinase inhibitor developed by Deciphera. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, which are involved in GIST. In addition, ripretinib inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, which is present in a subset of GIST. The INVICTUS study has demonstrated the significant efficacy of ripretinib in patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib was launched in the U.S. in 2020 under the brand name QINLOCK®. As of March 2026, it is approved for the treatment of advanced GIST in more than 40 countries or regions, including the U.S. and European countries. In Japan, ripretinib was designated as an orphan drug by the Ministry of Health, Labour and Welfare on March 19, 2026, for the treatment of GIST that have progressed following cancer chemotherapy. In addition, ripretinib was determined as a drug with high medical needs at the "67th Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs" held by Ministry of Health, Labour and Welfare, aiming to eliminate drug losses in Japan. Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology & inflammation, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA® is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. References: 1) Blay JY, Serrano C, Heinrich MC, et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020;21:923-34. 2) -CANCER STATISTICS IN JAPAN-2025. Available from: 3) Japan Society of Clinical Oncology, ed. Japanese Clinical Practice Guidelines for Gastrointestinal Stromal Tumors (GIST), Fourth Edition, April 2022. KANEHARA & Co., Ltd. Available from: The content above comes from the network. if any infringement, please contact us to modify.