Last mentioned: 3h ago
Market Impact
Moderna's valuation remains at roughly 10% of its pandemic-era high amid regulatory uncertainty.
Refusal to File
Senior regulator Vinay Prasad issues a rare letter refusing to review Moderna's flu vaccine application.
Grants Rescinded
The White House rescinds hundreds of millions in mRNA research grants as political rhetoric shifts.
Workaround Supported
FDA officials appear to support Moderna's plan to use data from a smaller trial as a workaround for control group concerns.
Collaboration Begins
Moderna starts working with the FDA on the design for its mRNA flu vaccine trials.
Moderna faces a critical setback after the FDA issued a rare refusal to review its flu vaccine application, signaling a shift in the regulatory and political climate for mRNA technology. This development, coupled with rescinded federal grants and a 90% decline in market value from pandemic peaks, highlights growing friction between the biotech industry and federal oversight.