Novavax, FDA
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
The U.S. Food and Drug Administration has put on hold a trial of Novavax's COVID-influenza and its standalone flu vaccines after a participant who took the combination shot reported nerve damage, the company said on Wednesday.
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
The vaccine maker said the regulator placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S.
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
Novavax reports FDA placed clinical hold on IND for COVID-flu combo vaccine
Novavax announced that the U.S. Food and Drug Administration has placed a clinical hold on Novavax’s Investigational New Drug, or IND, application for its COVID-19-Influenza Combination, or CIC, and stand-alone influenza vaccine candidates.
FDA slaps clinical hold on Novavax' COVID-19 flu combo trial IND
Shares of US protein-based vaccine maker Novavax closed down 19.4% at $10.15 yesterday having dropped as much as 24%, on the news of a setback for its investigational application for a covid vaccine.
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 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 16% 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’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.
Novavax gets EU authorization for updated COVID vaccine targeting JN.1 strain
The European Commission authorized Novavax's updated COVID-19 vaccine targeting the JN.1 strain of coronavirus in the region, ...
Robinhood, Novavax, Phunware, Lucid Group, And Tesla: Why These 5 Stocks Are On Investors' Radars Today
On Wednesday, major U.S. indices saw gains, with the Dow Jones Industrial Average climbing nearly 0.8% to 43,077.70.
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Cautious Optimism for Novavax Amid Clinical Hold Challenges
Roger Song has given his Buy rating due to a combination of factors that, despite current challenges, present potential upside for Novavax. The company is dealing with a clinical hold on its CIC ...