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Refusal to File
FDA's Vinay Prasad issues a formal refusal to review the flu vaccine application.
Grant Rescissions
The White House rescinds hundreds of millions in mRNA research funding.
Workaround Support
FDA officials reportedly signal acceptance of Moderna's alternative trial data submission.
Flu Vaccine Collaboration
Moderna begins working with the FDA on trial designs for its mRNA flu vaccine.
Peak Valuation
Moderna reaches a $200 billion market cap following global vaccine success.
The FDA's rare 'refusal to file' regarding Moderna's mRNA flu vaccine signals a pivot from pandemic-era collaboration to a more adversarial regulatory environment. This unpredictability, combined with rescinded federal grants and a 90% decline in market value, highlights the growing legal and compliance risks for biotech firms.