Novavax (NVAX) Awaits FDA Approval Following Additional Data Request | NVAX Stock News

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3 days ago
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Novavax, Inc. (NVAX, Financial) has provided an update regarding the status of its Biologics License Application (BLA) for its COVID-19 vaccine with the U.S. Food and Drug Administration (FDA). The company remains optimistic about the approval potential of its application, which has been under FDA review since its Prescription Drug User Fee Act (PDUFA) date on April 1.

The FDA has recently communicated with Novavax, requesting additional clinical data as part of a postmarketing commitment. Novavax is preparing to engage with the FDA promptly to address this request and expedite the approval process.

The company is focused on fulfilling the FDA's requirements and anticipates moving forward with its application in a timely manner. This development represents a crucial step in bringing Novavax's COVID-19 vaccine to market, pending the necessary regulatory approvals.

Wall Street Analysts Forecast

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Based on the one-year price targets offered by 6 analysts, the average target price for Novavax Inc (NVAX, Financial) is $17.33 with a high estimate of $25.00 and a low estimate of $9.00. The average target implies an upside of 177.33% from the current price of $6.25. More detailed estimate data can be found on the Novavax Inc (NVAX) Forecast page.

Based on the consensus recommendation from 7 brokerage firms, Novavax Inc's (NVAX, Financial) average brokerage recommendation is currently 2.3, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Based on GuruFocus estimates, the estimated GF Value for Novavax Inc (NVAX, Financial) in one year is $5.64, suggesting a downside of 9.76% from the current price of $6.25. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Novavax Inc (NVAX) Summary page.

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I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.