Accessibility StatementSkip Navigation RAMAT-GAN, Israel, Nov. 17, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced today results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol's effect on overcoming drug resistance in gastrointestinal (GI) cancers. The collaboration is based on breakthrough findings pub ...

Core Insights - Exelixis Inc. stock is experiencing a decline following the release of detailed results from the STELLAR-303 Phase 3 trial, which evaluated zanzalintinib in combination with Roche's Tecentriq against Bayer's Stivarga for metastatic colorectal cancer [1][6] Group 1: Trial Results - The STELLAR-303 trial met one of its dual primary endpoints, showing a 20% reduction in the risk of death in the intention-to-treat population at the final analysis [2] - At a median follow-up of 18 months, median overall survival was 10.9 months for the zanzalintinib and atezolizumab combination compared to 9.4 months for regorafenib [2] - The 12- and 24-month landmark overall survival estimates were 46% and 20% for the combination, versus 38% and 10% for regorafenib [4] Group 2: Additional Findings - An interim analysis indicated a trend favoring the combination with overall survival of 15.9 months compared to 12.8 months at a median follow-up of 16.8 months [5] - A trend for improvement in progression-free survival (PFS) was also observed, although statistical superiority cannot be claimed at this time due to the prespecified hierarchical testing strategy [5][6] - The trend for PFS improvement was consistent across subgroups [6]

Core Viewpoint - Exelixis, Inc. reported mixed results for Q2 2025, with adjusted earnings beating estimates but revenues missing expectations, leading to a decline in stock price in pre-market trading [2][3][25] Financial Performance - Adjusted earnings were 75 cents per share, exceeding the Zacks Consensus Estimate of 65 cents, but down from 84 cents in the same quarter last year [2][8] - Net revenues totaled $568.3 million, missing the Zacks Consensus Estimate of $579 million and reflecting a 10.8% year-over-year decline [3][8] - Net product revenues were $520 million, marking an 18.8% increase year-over-year, primarily driven by increased sales volume [5][8] Product Performance - Cabometyx generated revenues of $517.9 million, falling short of the Zacks Consensus Estimate of $527 million but surpassing the model estimate of $511.3 million [6][8] - The demand for Cabometyx's new indication for neuroendocrine tumors accounted for just over 4% of total demand in Q2, with expectations for growth [9][25] Collaboration and Revenue Sources - Collaboration revenues plummeted 70% to $48.2 million from $199.6 million in the prior year, largely due to a significant milestone payment recognized in the previous quarter [10][25] Expenses - Research and development expenses were $200.3 million, down 5.1% year-over-year, while selling, general, and administrative expenses rose 2.1% to $134.9 million [11][25] Stock Repurchase Program - Exelixis has repurchased $796.3 million of its common stock at an average price of $36.69 per share, with $204 million remaining under the current repurchase plan [12][13] Guidance - The company maintains its 2025 revenue guidance of $2.25 billion to $2.35 billion, with net product revenues expected between $2.05 billion and $2.15 billion [14][15] Pipeline Developments - Exelixis is advancing its pipeline with zanzalintinib, which has shown promising results in the STELLAR-303 study for metastatic colorectal cancer [16][18] - The company has three ongoing phase I studies and plans to initiate a phase I study for XB371 soon [23] Legal Settlement - In July 2025, Exelixis settled patent litigation with Biocon Pharma, allowing Biocon to market a generic version of Cabometyx in the U.S. starting January 1, 2031, if approved [24]