Novavax (NVAX) Files for Provisional Approval of its COVID-19 Vaccine in New Zealand

Novavax (NVAX) Files for WHO Emergency Use Listing of its COVID-19 Vaccine

November 4, 2021 4:02 PM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.

"Today's submission reflects our continued focus on accelerating access and equitable distribution as we work to bring our vaccine to people in need around the globe," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We continue to work with urgency to deliver our COVID-19 vaccine, built on a proven,... More

Novavax (NVAX) CEO Says Expects Decision On Its Covid-19 Vaccine From Regulators In India And Others In "Weeks, Not Months" - Reuters

November 1, 2021 12:51 PM EDT

Novavax (NASDAQ: NVAX) CEO Says Expects Decision On Its Covid-19 Vaccine From Regulators In India And Others In "Weeks, Not Months" - Reuters

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Novavax (NVAX) Expects To Produce 150 Million Doses A Month By Dec. - Bloomberg, Citing CEO

November 1, 2021 11:49 AM EDT

Novavax (NASDAQ: NVAX) Expects To Produce 150 Million Doses A Month By Dec. - Bloomberg, Citing CEO

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Pre-Open Stock Movers 11/01: (ANIP) (LDI) (HOG) Higher; (BTBT) (TRIP) (CRWD) Lower (more...)

November 1, 2021 9:29 AM EDT

Pre-Open Stock Movers:

Bit Digital, Inc. (NASDAQ: BTBT) 17% LOWER; gives back some of Friday's late-day surge.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 15.5% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has approved the Companys supplemental New Drug Application (sNDA) for Purified Cortrophin Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due... More

Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says

November 1, 2021 8:52 AM EDT

By Carl O'Donnell and Dania Nadeem

(Reuters) -Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within "weeks," its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.

Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.

For Indonesia, the shot will be manufactured by the world's largest vaccine manufacturer, Serum Institute in India (SII), and sold under the... More

Novavax (NVAX) and Serum Institute of India Granted Emergency Use Authorization for Novavax' COVID-19 Vaccine in Indonesia

November 1, 2021 6:23 AM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX.

"The first... More

Novavax (NVAX) Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to EMA

November 1, 2021 6:20 AM EDT

Health Canada filing marks first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in CanadaSubmission of all modules required for regulatory review, including CMC and clinical data, are now complete for European Medicines Agency

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada.... More