Novavax, influenza vaccine and FDA
Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge
The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial.
Novavax’s stock slides 19% after FDA puts clinical hold on COVID and flu vaccine candidates
Novavax Inc.’s stock tumbled 16% early Wednesday after the company said the FDA has placed a clinical hold on its COVID-19-and-flu combination and stand-alone flu vaccine candidates, following a case of motor neuropathy in a participant in a mid-stage trial.
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and standalone flu inoculation, sending shares down sharply.
FDA puts Novavax's phase 3 plan for pair of vaccine programs on hold over nerve disease case
Novavax’s plans for growth outside of its COVID program have been thrown into chaos after the FDA put the biooharma's flu programs on hold in response to a case of nerve disease from a former parti | The phase 2 trial wrapped up in July 2023,
Novavax Stock Plunges as FDA Puts Hold on Vaccines Because of Safety Concerns
The Food and Drug Administration put clinical holds on Novavax's COVID-19 and flu combination vaccine and its standalone flu shot because of safety concerns.
Novavax Stock Plunges After FDA Pauses Covid, Flu Vaccine Trials
Novavax shares tumbled after the Food and Drug Administration put a clinical hold on its testing applications for a combined Covid-flu vaccine and standalone flu inoculation due to safety concerns. Fi
FDA Freezes COVID-Flu Combo Vaccine Trial Over Safety Concern
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 Shares Slide as FDA Pauses COVID/Flu Vaccine Candidates
The clinical hold affects Novavax’s COVID-flu combo and standalone flu vaccines, which were on the cusp of Phase III testing. The FDA’s decision stems from a report of a serious adverse event of motor neuropathy,
Novavax shares plunge after FDA places a hold on its flu shots
Novavax Inc. shares fell 20% after US regulators placed a hold on the development of its experimental flu vaccines following a severe adverse event that occurred in a single clinical trial participant.
Novavax Stock Falls After FDA Puts Two Vaccine Programs on Hold
Shares of Novavax NVAX lost nearly 20% on Wednesday after the company announced that the FDA has placed a clinical hold on its experimental COVID-19-Influenza Combination (“CIC”) and stand-alone influenza vaccine candidates.
How Bad Is This News for Novavax?
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Reuters4d
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
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 ...
Daily4d
Novavax faces setback as USFDA halts COVID-Flu vaccine trial over nerve damage report
Novavax said a participant enrolled in a mid stage study of the combination vaccine last month reported symptoms of motor ...
NOLA.com7d
Don't call them boosters: Here's what to know about the flu and COVID vaccines this fall
Flu season is emerging and, although the disease is not predicted to be as prominent as years past, doctors urge people to ...
Novavax’s Regulatory Setback and Mid-Term Underperformance: An Analyst’s Perspective
Analyst Eric Joseph of J.P. Morgan maintained a Sell rating on Novavax (NVAX – Research Report), retaining the price target of $9.00.