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VisitFDA Places Clinical Hold on Novavax's COVID-19 and Flu Vaccine Candidates, Shares Drop 20%
Oct 16, 2024, 01:21 PM
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's COVID-19 and influenza combination vaccine, as well as its standalone influenza vaccine candidates. The hold was prompted by a serious adverse event (SAE) reported in a trial participant, which involved motor neuropathy. Following the announcement, Novavax shares experienced a significant decline, dropping by as much as 20%, with a notable 16% and 18.7% drop at different points. The clinical hold aims to address safety concerns and ensure the well-being of trial participants.
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Clinical hold lifted with no changes • 25%
Clinical hold lifted with additional requirements • 25%
Clinical hold maintained • 25%
Clinical hold converted to full stop • 25%
Safety concerns resolved • 25%
Further investigation required • 25%
Vaccine trials permanently halted • 25%
Other outcome • 25%
Yes • 50%
No • 50%
Partnership with another company • 25%
Focus on different vaccine candidates • 25%
Continue with current strategy • 25%
Other strategic response • 25%
Yes • 50%
No • 50%
Resume trials • 25%
Modify trial protocols • 25%
Abandon trials • 25%
Seek alternative partnerships • 25%
Stays within +/- 10% • 25%
Decreases by more than 10% • 25%
Increases by more than 20% • 25%
Increases by 10% to 20% • 25%