Aachen, Germany, September 21, 2026
Grünenthal has announced an agreement with Bayer AG to acquire Stivarga® (regorafenib), an established oral treatment used for certain advanced cancers, in a transaction valued at up to €375 million. The acquisition represents the latest step in Grünenthal’s strategy of acquiring established medicines that address clear medical needs while leveraging the company’s commercial and operational capabilities. The transaction remains subject to customary closing conditions, including approval from relevant regulatory authorities, and is expected to close by the end of 2026 or early 2027. Stivarga is already approved and available in more than 90 markets worldwide, providing Grünenthal with an established international oncology product and an opportunity to expand its pharmaceutical portfolio beyond its core focus on pain management.
Grünenthal Expands Established Medicines Portfolio
Stivarga (regorafenib) is a once-daily oral multikinase inhibitor indicated for specific patients with advanced cancer who have previously received, or are unable to receive, other available treatments. Its approved indications include metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC). According to Grünenthal, the medicine has treated more than one million patients across more than 90 countries over 10 years, establishing a significant global commercial and clinical footprint. In the European Union, Stivarga is approved for adults with metastatic colorectal cancer following specified previous therapies, adults with unresectable or metastatic GIST following treatment with imatinib and sunitinib, and adults with hepatocellular carcinoma previously treated with sorafenib. In the United States, its approved uses similarly cover specified patients with metastatic colorectal cancer, advanced GIST and hepatocellular carcinoma following prior therapies.
The acquisition will allow Grünenthal to add an established oncology medicine to its portfolio while applying its existing commercial infrastructure and operational capabilities. The company said the transaction is expected to be immediately accretive to its business. Grünenthal estimates that Stivarga could contribute a positive impact of up to approximately €100 million to consolidated EBITDA for 2027, assuming the transaction closes by the end of 2026 or early 2027 and the product is consolidated for a full year. The company also noted that loss of exclusivity for Stivarga is anticipated in 2029 in the European Union and 2030 in the United States, factors that will be relevant to the product’s future commercial profile.
$2.6 Billion M&A Strategy Supports Growth
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The Stivarga transaction continues Grünenthal’s broader M&A strategy, which has focused on acquiring established medicines that address ongoing healthcare needs and can benefit from the company’s commercial and operational expertise. Grünenthal reports that it has invested approximately €2.6 billion in successful M&A transactions since 2017. Previous transactions have included global rights to Nebido™, Vimovo™, Zomig™ and Qutenza™, rights to Cialis® in Mexico, Brazil and Colombia, European rights to Crestor™ and Nexium™, and the acquisition of Movantik® through its 2024 acquisition of U.S.-based Valinor Pharma. Earlier in 2026, Grünenthal also acquired full ownership of Grünenthal Meds, a previously jointly owned venture with Kyowa Kirin International focused on marketing established medicines. The company said these transactions have strengthened its profitability and supported further investment in its innovative research pipeline. The proposed Stivarga acquisition therefore fits into an established pattern of portfolio expansion through targeted acquisitions rather than representing an isolated transaction.
Stivarga Adds Global Oncology Reach
With Stivarga, Grünenthal will acquire an established medicine with a presence across more than 90 markets and a decade of patient use. Regorafenib works by inhibiting multiple kinases involved in tumor growth, tumor angiogenesis and the tumor microenvironment, providing a targeted pharmacological approach for several advanced cancers. The medicine’s existing approvals and established commercial infrastructure are expected to provide Grünenthal with a platform for continued management and commercialization of the product following completion of the transaction. The acquisition remains subject to regulatory approvals and other customary closing conditions, meaning ownership has not yet transferred to Grünenthal. If completed as anticipated, the transaction would further diversify the company’s established-medicines portfolio and strengthen its presence in oncology, while continuing its strategy of using M&A to support long-term growth. The deal also demonstrates the ongoing pharmaceutical industry trend of established companies acquiring marketed medicines to expand therapeutic reach and leverage existing commercial capabilities.
Source: Grünenthal, Bayer press release
