Business
Novavax Reports Third Quarter 2021 Financial Results and Operational Highlights
- Received EUA for NVX-CoV2373 in Indonesia in partnership with Serum Institute of India - Completed regulatory submissions in the U.K., Australia, Canada,
About this update from Novavax, Inc.
[{"type":"text","content":"- Received EUA for NVX-CoV2373 in Indonesia in partnership with Serum Institute of India\n - Completed regulatory submissions in the U.K., Australia, Canada, New Zealand, EU, India, the Philippines and to the WHO\n - Expect to submit complete regulatory package to the U.S. FDA by end of 2021\n - Company to host conference call today at 4:30 p.m. ET\n\n\nGAITHERSBURG, Md., Nov. 4, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2021.\n\"We are excited by the significant progress made over the quarter, including our landmark milestone of gaining the first regulatory approval for our COVID-19 vaccine,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"With additional regulatory submissions around the world, we are prepared to deliver our vaccine globally. We believe the highly encouraging results from our six-month booster study complement the strong efficacy demonstrated by NVX-CoV2373 to date, and we remain confident that our vaccine will serve as an important tool to fight COVID-19 in the years to come.\"\nThird Quarter 2021 and Recent Highlights\nCOVID-19 Vaccine Regulatory Pathway\nReceived emergency use authorization (EUA) from National Agency of Drug and Food Control of the Republic of Indonesia, in partnership with Serum Institute of India Pvt. Ltd. (SII) NVX-CoV2373 to be marketed by SII under the brand name COVOVAX™Novavax completed multiple regulatory submissions U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for conditional marketing authorization Australia Therapeutic Goods Administration (TGA) for provisional approval Health Canada for authorization New Zealand Medsafe for provisional approval World Health Organization (WHO) for emergency use listing (EUL) European Medicines Agency (EMA) (submitted all final data and modules)SII, our licensee, completed multiple regulatory submissions for our COVID-19 vaccine Drugs Controller General of India (DCGI) and the Philippines for EUA WHO for EULExpect to submit the complete regulatory package to the U.S. FDA by the end of 2021COVID-19 Vaccine Advanced Purchase Agreements\nExecuted advance purchase agreem...