Core Insights - Bayer AG's pipeline candidate asundexian has successfully met primary efficacy and safety endpoints in the late-stage OCEANIC-STROKE Study for secondary stroke prevention [1][9] - The study demonstrated that asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo when combined with antiplatelet therapy [1][4] - Bayer plans to submit marketing authorization applications globally for asundexian following the positive study results [2][9] Study Details - The OCEANIC-STROKE study was a phase III randomized, placebo-controlled, double-blind trial evaluating asundexian's efficacy and safety in preventing ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack [3] - Results indicated that asundexian showed superiority over placebo in reducing ischemic stroke risk without increasing the rate of ISTH major bleeding [4][9] - Approximately 12 million people experience a stroke annually worldwide, with 20-30% at risk for recurrent strokes [4] Market Context - Despite existing therapies, the risk of recurrent strokes remains significant, with one in five stroke survivors experiencing another stroke within five years [5] - Stroke is the second leading cause of death globally, and recurrent ischemic events are often more disabling and associated with higher mortality [5] - The FDA has granted Fast Track Designation to asundexian, which could significantly enhance Bayer's pharmaceutical portfolio given the prevalence of secondary stroke [6] Bayer's Pharmaceutical Strategy - Bayer is actively working to broaden and diversify its pharmaceutical business, with recent progress noted in its key drugs, including Nubeqa for cancer and Kerendia for chronic kidney disease [7] - The decline in sales of Xarelto, co-developed with Johnson & Johnson, is being offset by growth from these key drugs [7][8] - Bayer is also pursuing label expansions for Nubeqa and Kerendia, which could further drive sales growth [8] Stock Performance - Year-to-date, Bayer's shares have surged by 62.7%, significantly outperforming the industry average gain of 16% [10]