Novavax Says On Oct. 11, FDA Notified Co. It Placed Clinical Hold On IND For COVID-19-Influenza Combination And Standalone Influenza Vaccine Candidates Due To Spontaneous Report Of Serious Adverse Event Of Motor Neuropathy
Portfolio Pulse from Benzinga Newsdesk
Novavax announced that the FDA has placed a clinical hold on its investigational new drug applications for both its COVID-19-influenza combination and standalone influenza vaccine candidates. This decision follows a report of a serious adverse event involving motor neuropathy.
October 16, 2024 | 12:08 pm
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The FDA has placed a clinical hold on Novavax's COVID-19-influenza combination and standalone influenza vaccine candidates due to a serious adverse event report. This could delay the development and approval process for these vaccines.
The FDA's decision to place a clinical hold is a significant regulatory setback for Novavax, likely causing delays in the development and approval of their vaccine candidates. This could negatively impact investor sentiment and the stock price in the short term.
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