Nuvaxovid™ is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S.Biologics License Application approval triggers $175 million Sanofi milestone payment, with additional COVID-19 vaccine milestones and ongoing tiered royalties to be recognized when earned

GAITHERSBURG, Md., May 19, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™ for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).1 Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi.

FDA feedback on COVID-19 BLA suggests pathway to approval upon alignment on study parameters for the postmarketing commitment requested by FDASHIELD-Utah study demonstrates that Nuvaxovid® resulted in fewer and less severe reactogenicity symptoms when compared to marketed mRNA vaccine; Nuvaxovid recipients experienced approximately 39% fewer symptoms on averageData presented at World Vaccine Congress showcases Matrix-M® utility when co-administered with a broad array of vaccine platforms and diseasesStrengthened partnership with Takeda in Japan, the third largest pharmaceutical market, with significant improvement in financial termsRaises full year 2025 revenue framework to between $975 million and $1,025 million Reiterates full year 2025 financial guidance for combined R&D and SG&A expenses of between $475 million and $525 millionRecorded total revenue of $667 million in the first quarter of 2025Company to host conference call today at 8:30 a.m. ET

GAITHERSBURG, Md., May 7, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it will participate in the BofA Securities 2025 Health Care Conference.

Conference Details:

Fireside Chat

Date:

Wednesday, May 14, 2025

Time:

3:00 – 3:30 p.m. Pacific Time (PT)

Location:

Las Vegas, NV

Conference

Event:

Investor Meetings

Date:

Wednesday, May 14, 2025

A webcast of the fireside chat will be available on the Events & Presentations page of the Company's website at ir.novavax.com. A replay of the webcast will be available for 30 days.

Improved financial terms for Novavax and streamlined operations will help both companies better meet the needs of the Japanese market Nuvaxovid®, a protein-based, non-mRNA COVID-19 vaccine, will continue to be available in Japan, the world's third largest pharmaceutical market

GAITHERSBURG, Md., May 5, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) has updated the terms of the previously announced collaboration and licensing agreement (CLA) with Takeda. The improved financial terms of the amended agreement for the development, manufacturing and commercialization of Nuvaxovid® in Japan include an upfront payment, payment related to the 2024/2025 season, annual milestones associated with regulatory approvals and royalties on net sales earned every season moving forward.

GAITHERSBURG, Md., May 1, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced it will report its first quarter 2025 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Thursday, May 8, 2025. Details of the event and replay are as follows:

Conference call details:

Date:

May 8, 2025

Time:

8:30 a.m. U.S. ET

URL to register phone:

https://emportal.ink/43UHjFq

Dial-in number:

(800) 836-8184 (Domestic) or

(+1) (646) 357-8785 (International)

Webcast:

ir.novavax.com/events

GAITHERSBURG, Md., April 29, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced the appointment of Charles Newton to its board as an independent director. Mr. Newton brings extensive experience in public markets and healthcare investment banking to his role on the Novavax Board of Directors.

"Charles brings a wealth of expertise across corporate finance and capital markets to Novavax," said John C. Jacobs, President and Chief Executive Officer, Novavax. "The knowledge he brings to our already experienced board will be invaluable as we continue to execute our corporate growth strategy focused on forging strategic partnerships for our R&D assets and our Matrix-M® adjuvant." 

Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccineFull results will be submitted for publication later this year

GAITHERSBURG, Md., April 15, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced preliminary results from the SHIELD-Utah study (Study of Healthcare Workers and First Responders Investigating Effects of Systemic and Local reactogenicity of COVID-19 Vaccine Doses in Utah) that showed Novavax's COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) targeting the JN.1 strain resulted in fewer and less severe reactogenicity symptoms, when compared with the Pfizer-BioNTech mRNA 2024-2025 vaccine. This real-world study conducted between September and December 2024 in partnership with the University of Utah Health, also showed that the impact of symptoms on daily activities, including work and family responsibilities, was lower in recipients of Novavax's vaccine. The results were presented today at the Congress of the European Society of Clinical Microbiology and Infectious Diseases 2025.

James Young, PhD retires as Chair of the Board, Margaret McGlynn, RPh, appointedJohn Shiver, PhD appointed to board of directors

GAITHERSBURG, Md., March 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that James Young, PhD, is retiring as Chair of the Board and Margaret McGlynn, RPh, has been appointed as his successor. The Company also appointed John Shiver, PhD, to its board as an independent director.

GAITHERSBURG, Md., Feb. 27, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), today announced that the management team will participate in the following upcoming investor conferences:

TD Cowen 45th Annual Health Care Conference:

Fireside Chat

Date:

Tuesday, March 4, 2025

Time:

9:10 – 9:40 a.m. Eastern Time (ET)

Location:

Boston, MA

 

Conference

Event:

Investor Meetings

Date:

Tuesday, March 4, 2025

Leerink Partners 2025 Global Healthcare Conference:

Presentation

Date:

Tuesday, March 11, 2025

Time:

3:40 – 4:10 p.m. ET

Location:

Miami Beach, FL

 

Conference

Event:

Investor Meetings

Date:

Tuesday, March 11, 2025

Jefferies Biotech on the Beach Summit:

Conference

Event:

Investor Meetings

Date:

Wednesday, March 12, 2025

Location:

 

Miami Beach, FL

Transitioned lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine to Sanofi beginning with the 2025-2026 season Achieved total revenue of $88 million in the fourth quarter of 2024 and $682 million for the full year 2024 Achieved $50 million milestone under Sanofi agreement associated with the pediatric clinical trial database lock for the first cohortCompleted $200 million sale of Czech Republic manufacturing facility to Novo Nordisk; reduces annual costs by approximately $80 millionAdvanced pipeline programs, based on proven and innovative technology platformEnded full year 2024 with over $1 billion in Cash and accounts receivablesProvides 2025 financial guidance and revenue framework Company to host conference call today at 8:30 a.m. ET