The U.S. Food and Drug Administration has put on hold a trial of Novavax’s (NVAX.O) COVID-influenza and its standalone flu vaccines after a participant who took the combination shot reported nerve damage, the company said on Wednesday.
Its shares plunged as much as 24%, and if losses hold, it would wipe off nearly $400 million from the vaccine maker’s market capitalization.
The stock drop also reflect concerns on whether the hold would impact Novavax’s partnership with French drugmaker Sanofi (SASY.PA), according to one analyst.
The Food and Drug Administration halted Novavax’s trial of a combination vaccine for COVID and influenza, as well as a standalone flu shot, after a participant suffered a serious adverse event, the company said on Wednesday.
Novavax’s share price fell more than 18% on the news.
Novavax Inc. shares experienced a significant drop of as much as 24% after the United States regulators issued a hold on the companyβs experimental influenza and Covid-19 combination vaccines. This decision came after a volunteer in a study developed a severe nerve disorder. According to a statement released by the US Food and Drug Administration (FDA), the pause affects both Novavaxβs standalone influenza shots and the combination vaccine.
Robert Walker, the Chief Medical Officer of Novavax, stated that the company does not believe a direct link has been established between the vaccine and the reported neuropathy case, and they are actively collaborating with regulators to clarify the issue. At 11:54 AM, Novavax shares fell 18%, marking their steepest decline since July.
