Tag Archives: Novavax

Novavax (NVAX) is awaiting the FDA’s decision on its COVID-19 vaccine booster, and whether or not the agency will accept the original formula rather than a new variant-specific formula. However, the company is expecting the FDA to green-light the booster as an option even for those who received other vaccines for their primary or previous booster doses. That’s according to chief commercial officer John Trizzino. While Novamax already received booster approval in other countries, the U.S…. Source link

Novavax (NVAX) missed Wall Street expectations Monday after its second quarter earnings showed softer-than-expected demand in global vaccine sales, forcing the company to slash its 2022 outlook by 50% to $2 billion. While at least $400 million in revenue has come in since July 1, the company has not fulfilled orders for low- and middle-income countries (LMICs) through the global COVAX program and anticipates no further orders from the U.S. this year, according to company executives Monday. But… Source link

The FDA’s vaccine advisory committee voted in favor of Novavax’s (NVAX) COVID-19 vaccine for use in adults, paving the way for the company to get its first product authorized in the U.S. But the day-long meeting raised a number of concerns presented by Novavax’s late entry to the vaccine field. Before any data was even presented, questions were raised by committee members about the need to authorize yet another COVID-19 vaccine, as demand has waned in the U.S., and about the manufacturing… Source link

Novavax (NVAX) is awaiting the outcome of a June 7 meeting of the FDA’s vaccine advisory committee, which could finally bring its COVID-19 vaccine to the U.S. market. Chief Commercial Officer John Trizzino told Yahoo Finance in an exclusive interview Wednesday that the company is optimistic about the upcoming meeting. Novavax ran into manufacturing quality problems in early 2021 and experienced subsequent delays in its Phase 3 trial in the U.S., forcing the company to push back its timeline… Source link

GAITHERSBURG, Md., Feb. 28, 2022 /PRNewswire/ — NVX-CoV2373 is the first protein-based COVID-19 vaccine authorized in multiple major markets around the world, including the European Union, Australia, Canada, and Great Britain; authorizations granted by 12 regulatory agencies and emergency use listing from the WHO Additional filings for authorization under review, including in the United States Initiated vaccine shipments globally, with doses administered in the European Union, Australia,

Stock futures fell, oil prices jumped and Russian authorities scrambled to keep a grip on domestic markets, as investors rushed to adjust to geopolitical developments including new sanctions against Russia. Here’s what we’re watching in Monday’s trading: NIO shares added 1% premarket. The electric-vehicle maker plans to list shares in Hong Kong, joining other Chinese businesses pursuing an additional listing outside New York amid the threat of being forced off… Source link

Novavax (NVAX) announced Thursday it would have to push back its COVID-19 vaccine emergency use authorization (EAU) filing with the FDA by about one month, once again, this time due to manufacturing quality concerns. CEO Stanely Erck told Yahoo Finance Novavax itself did not delay the filing. Instead, he said, outside firms that the company was directed to work with by Operation Warp Speed — the former government program launched under the Trump administration to fund six vaccine candidates… Source link

Delays for the regulatory filings of its Covid-19 vaccine NVX-CoV2373 (NUVAXOVID) have meant Novavax (NVAX) has been unable to get its offering out to the public yet. You would think that with other leading players firmly planted in the public and health policy makers’ consciousness, maybe the opportunity has already passed for last year’s outstanding performer. However, in late-stage studies, the vaccine’s data has shown to be just as good as those of the leading approved vaccines…. Source link

Bloomberg FDA Clears Pfizer Shot for Teens; U.S. Cases Slow: Virus Update (Bloomberg) — The U.S. Food and Drug Administration approved the use of Pfizer-BioNTech vaccine for children aged 12 to 15. The number of new cases in U.S. rose last week at the slowest pace since the pandemic began, as more Americans are vaccinated and the nation recovers from a winter spike fueled by holiday travel.India’s capital of New Delhi extended its lockdown for another week as it battled a wave of infections… Source link

Bloomberg Just How Big and Important Is Sanjeev Gupta’s Metals Empire? (Bloomberg) — Sanjeev Gupta is fighting to save his sprawling empire after Greensill Capital, its biggest lender, collapsed into administration.While the markets for GFG Alliance’s steel mills and aluminum smelters are buoyant, a court filing revealed on Monday that Gupta’s group had told Greensill in February that it would be insolvent without its funding.That casts a shadow over operations that employ about 35,000… Source link