Novavax, Inc. (NVAX) stock prices were up by a marginal 2.31% as of the market closing on June 11th, 2021, bringing the price per share up to USD$209.68 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock surge by 6.57%, bringing it up to USD$223.45.
Success of PREVENT-19
The company announced a massively positive outcome for NVX-CoV2373, demonstrating 100% protection against moderate and severe forms of the disease. The treatment also reported an overall efficacy of 90.4% and met its primary endpoint in the PREVENT-19 pivotal Phase 3 trial. The study consisted of a total of 29,960 participants, spanning 119 sites across Mexico and the U.S. The study was designed to evaluate the efficacy, safety, and immunogenicity of the treatment, with an emphasis on representation in the recruitment of communities and demographic groups most impacted by the disease.
Treatment Poised to Proliferate
With the world hurtling towards global immunizations as the global coronavirus pandemic continues to take its toll on economies, Novavax is closer to addressing the critical and persistent global public health need. The company continues to work at full capacity to facilitate the completion of regulatory submissions and deliver the vaccine. NVAX has secured a well understood platform with an established track record, through which they will facilitate the provision of the much needed vaccines.
Next Steps for NVAX
NVAX anticipates filing for regulatory authorizations in the third quarter of 2021, following the completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing, and controls (CMC) requirements. Following the approval, the company will see growth to a manufacturing capacity of 100 million doses per month by the end of the third quarter of 2021. The end of the fourth quarter is expected to mark the ramping up of manufacturing capacity to 150 million doses a month.
PREVENT-19 has consolidated the tolerability and safety profile of NVX-CoV2373, with data having shown consistent, high levels of efficacy and reaffirm the treatment’s capability to prevent Covid-19 as increasing variants of the virus proliferate international communities. To this end, the treatment has received support from the U.S government, including the DoD, BARDA, parts of the HHS, the NIAID, and more. As per a DoD agreement, BARDA will provide NVAX with USD$1.75 billion.
Future Outlook for NVAX
Armed with the fortuitous surge in the value of their equity, NVAX is poise to push for the commercialization and proliferation of its proprietary treatment. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.