Welcome to our dedicated page for Novavax news (Ticker: NVAX), a resource for investors and traders seeking the latest updates and insights on Novavax stock.
Novavax Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company dedicated to developing vaccines to prevent infectious diseases. Based in Gaithersburg, Maryland, with facilities in Rockville, Maryland, and Uppsala, Sweden, Novavax employs over 300 professionals focused on innovation in vaccine development.
Novavax leverages its proprietary recombinant nanoparticle technology and Matrix-M™ adjuvant to create vaccines that stimulate strong immune responses. The company's product pipeline includes vaccine candidates for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus. Additionally, their pipeline includes preclinical programs targeting various infectious diseases.
Recently, Novavax has made significant strides in COVID-19 vaccine development. The company announced that its Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) received Emergency Use Listing (EUL) from the World Health Organization (WHO). This listing expedites the regulatory approval process, enabling broader global distribution. The vaccine is also authorized in the U.S. and the European Union and is under review in other markets.
Novavax's updated COVID-19 vaccine can be stored at temperatures between 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying logistics and reducing waste. This vaccine has shown efficacy against multiple variants, including BA.2.86, EG.5.1, and XBB.1.16.6.
In addition to their COVID-19 efforts, Novavax has entered a co-exclusive licensing agreement with Sanofi to enhance the distribution of their standalone adjuvanted COVID-19 vaccine and develop combination vaccines. This partnership highlights the company's commitment to leveraging its technology to address global health challenges.
Financially, Novavax has shown a strong performance with updated financial guidance for 2024. With over $1 billion in potential contract value for advance purchase agreements, Novavax is well-positioned to deliver on its commitments while focusing on expanding its product portfolio.
Overall, Novavax Inc. represents a significant player in the biotechnology sector, continuously pushing the boundaries of vaccine development to address pressing global health issues.
Novavax, Inc. (Nasdaq: NVAX) has entered a license agreement with Serum Institute of India for the development and commercialization of its COVID-19 vaccine candidate, NVX-CoV2373, in low- and middle-income countries (LMIC) and India. The partnership aims to ensure a global supply of the vaccine, leveraging Serum Institute's extensive reach. Serum Institute gains exclusive commercialization rights in India and shared rights in other LMICs. The collaboration builds on Novavax's efforts with CEPI for equitable vaccine distribution through the COVAX Facility.
Novavax, a late-stage biotechnology company, will release its second quarter 2020 financial results on August 10, 2020, after U.S. market close. The conference call is scheduled for 4:30 p.m. ET, with dial-in numbers provided for domestic and international participants. The call will cover latest updates on Novavax's vaccine candidates, including NVX-CoV2373 for COVID-19 and NanoFlu, their influenza vaccine. Investors can access a webcast of the call and a replay available until August 17, 2020.
Novavax (NVAX) announced promising Phase 1 data for its COVID-19 vaccine candidate, NVX-CoV2373, which was generally well-tolerated and exhibited a reassuring safety profile. The trial involved 131 healthy adults aged 18-59 and demonstrated that 100% of participants achieved neutralization titers. Both 5 µg and 25 µg doses generated peak geometric mean titers exceeding 1:3,300. The Matrix-M adjuvant contributed to strong immune responses. The data will be submitted for peer review and available via a preprint server.
On July 23, 2020, Novavax (NASDAQ: NVAX) announced a collaboration with FUJIFILM Diosynth Biotechnologies for the large-scale manufacturing of its COVID-19 vaccine candidate, NVX-CoV2373, following a $1.6 billion funding award from Operation Warp Speed. The production has commenced in Morrisville, North Carolina, with the initial batch for upcoming Phase 3 clinical trials involving 30,000 subjects. The funding will also support clinical development, aiming to deliver 100 million doses by late 2020. Preliminary results from an ongoing Phase 1/2 trial in Australia are expected soon.
Novavax, Inc. (NASDAQ: NVAX) has partnered with FUJIFILM Diosynth Biotechnologies to manufacture bulk drug substance for its COVID-19 vaccine candidate, NVX-CoV2373. This collaboration is part of Novavax’s $1.6 billion funding from the U.S. government’s Operation Warp Speed, aimed at providing millions of vaccine doses by late 2020. Initial production has begun at FUJIFILM’s North Carolina facility, supporting a pivotal Phase 3 clinical trial expected to start in fall 2020. The vaccine is based on proprietary nanoparticle technology and aims to demonstrate safety and efficacy through extensive trials.
Novavax, Inc. (NASDAQ: NVAX) announced that Gregory M. Glenn, M.D. will present on the progress of NVX-CoV2373, its COVID-19 vaccine candidate, at the 2nd International Society for Vaccines Virtual Congress on July 21, 2020, at 9:55 a.m. ET. The NVX-CoV2373 vaccine is designed using recombinant nanoparticle technology and is funded by the U.S. Government with up to $1.6 billion through Operation Warp Speed. The Phase 1 clinical trial commenced in May 2020, with preliminary results expected in July 2020.
Novavax, Inc. (Nasdaq: NVAX) announced its selection for Operation Warp Speed, receiving a $1.6 billion award to advance its COVID-19 vaccine, NVX-CoV2373. This funding will support late-stage clinical trials, including a pivotal Phase 3 trial with up to 30,000 subjects, and large-scale manufacturing of 100 million doses. Preliminary safety results from a Phase 1/2 trial are expected by late July 2020, with additional support from CEPI amounting to $388 million. This partnership aims to expedite vaccine delivery amid the COVID-19 pandemic.
Novavax, Inc. (NASDAQ: NVAX) announced the appointment of Frank Czworka as Senior Vice President, Global Sales, and the promotion of Brian Webb to Senior Vice President, Manufacturing. Czworka, with over 20 years of experience, has previously held senior roles in biopharmaceutical sales and marketing. Webb has been instrumental in expanding manufacturing capabilities. The company aims to advance its COVID-19 vaccine candidate, NVX-CoV2373, and its quadrivalent influenza nanoparticle vaccine, NanoFlu, to the market, intending to positively impact global health.
Novavax (NASDAQ: NVAX) announced the appointment of Ben Machielse as Executive Vice President, CMC, on June 29, 2020. Machielse will oversee manufacturing and regulatory functions as the company advances its COVID-19 vaccine candidate, NVX-CoV2373. Other leadership promotions include John Trizzino as Chief Business Officer and CFO, John Herrmann III as Chief Legal Officer, and Jill Hoyt as Chief Human Resources Officer. Novavax is ramping up its manufacturing capacity for its vaccines, which include NVX-CoV2373 and NanoFlu, with clinical trial results expected soon.
Novavax, a biotechnology company focused on vaccines, will have its Chief Business Officer, John J. Trizzino, participate in the H.C. Wainwright Virtual Fireside Chat on June 25, 2020, at 10:00 a.m. ET. The discussion will center on Novavax's COVID-19 vaccine candidate, NVX-CoV2373. This candidate is part of Novavax's broader mission to develop innovative vaccines, including the NanoFlu™, which recently succeeded in a Phase 3 trial. More insights can be found on Novavax's website.
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