FDA Refusal to Review Flu Vaccine Sparks 14% Drop in Moderna Shares
FDA declined to review Moderna’s approval application for its new influenza vaccine, prompting shares to open 14% lower in Frankfurt. Trading volume remained light following the setback, marking Moderna’s first major regulatory rejection in its seasonal shot program.
1. FDA Refusal on Flu Vaccine Review
The FDA formally declined to accept Moderna’s approval application for its seasonal influenza vaccine, citing regulatory concerns over the submitted data package. This marks the first time a major mRNA flu candidate from the company has been rejected before formal review.
2. Share Price Impact in Frankfurt
In response to the announcement, Moderna’s stock opened down 14% on the Frankfurt exchange, trading at sharply reduced volumes. Investors weighed the setback against the broader biotech rally, driving a swift sell-off in early trading.
3. Company Outlook and Next Steps
Moderna is evaluating the FDA’s feedback to identify data gaps and potential amendments. The company is considering a resubmission after addressing the deficiencies, while analysts will reassess timelines for its flu vaccine commercial rollout.