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Merck–Moderna Cancer-Vaccine Trial Win Sends Stocks Higher

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Merck and Moderna said their personalized mRNA cancer vaccine, intismeran autogene, met the primary endpoint in the Phase 3 INTerpath-001 trial for high-risk melanoma. Used alongside Merck’s Keytruda, the vaccine significantly improved recurrence-free survival versus Keytruda alone and also reduced the risk of cancer spreading to distant organs. The trial enrolled 1,137 patients with stage IIB–IV melanoma whose tumors had been surgically removed. No new safety concerns were reported, and the study will continue tracking overall survival. The result is being described as the first positive Phase 3 readout for an individualized neoantigen or mRNA cancer vaccine, and the first late-stage trial to demonstrate a meaningful improvement over Keytruda alone in this setting. Moderna’s shares surged—at points more than doubling—while Merck gained roughly 10%–12%, adding tens of billions of dollars to Moderna’s market value. Investors and analysts are now debating whether intismeran cou...

Regeneron’s Pasatru wins FDA approval for ultra-rare FOP bone-growth disorder

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Lp(a): Why biotech is betting on the “diabolical” molecule

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Clinical development enters the digital age

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FDA approves Ultragenyx gene therapy for glycogen storage disease type Ia

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Rebounding biotech funding could lift CDMO demand within a year

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Merck–Moderna Personalized Cancer Vaccine Shows Positive Phase 3 Results

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Trump nominates White House aide Heidi Overton to lead the FDA

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Lilly’s Amylin Drug Debate Intensifies Ahead of Crucial Weight-Loss Data

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BioMarin buys early-stage oral bone-disease drug from Alesta

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Trump claims credit for falling drug prices, but Biden-era Medicare negotiations likely played a major role

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Cortechs.ai Wins FDA Clearance for NeuroQuant PET

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WHOOP opens Advanced Labs to non-members and adds GRAIL’s Galleri cancer test

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