Novavax Shares Slump After 2Q Revenue Misses Estimate
The U.S. Food and Drug Administration has put a trial of Novavax’s COVID-influenza and its standalone flu vaccines on hold after a participant who took the combination shot reported nerve damage, the company said.
Novavax said a participant enrolled in a mid-stage study of the combination vaccine last month reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement. The person was given the vaccine in January last year.
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“Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible,” Chief Medical Officer Robert Walker said.
Stock drop
Still, the pause fueled investor worries over the company’s growth as its COVID-19 shot, Novavax’s only approved product, faces low demand after a late entry into the U.S. market.
Its shares plunged as much as 24 percent. If losses hold, it would wipe off nearly $400 million from the vaccine maker’s market capitalization.
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The company in May had signed a deal worth at least $1.2 billion with Sanofi to co-sell Novavax’s vaccine in most countries and use the COVID shot along with its own flu vaccines to develop a combination shot.
Sanofi said the clinical hold has “nothing to do with” its partnership with Novavax. Outside of the agreement, the companies can individually develop their own flu-COVID vaccines and other products, it said in an e-mailed statement.
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Investors will closely monitor what additional data the FDA asks for, he said.
(Reporting by Bhanvi Satija and Leroy Leo in Bengaluru; Editing by Anil D’Silva, Arun Koyyur and Sriraj Kalluvila)
* Original Article:
https://www.inc.com/reuters/fda-freezes-covid-flu-combo-vaccine-trial-over-safety-concern/90990372
