Novavax, Inc. (NASDAQ:NAVX) stock traded higher on Wednesday.
In an SEC filing, Novavax said, “We believe that our Biologics License Application (BLA) is approvable based on conversations with U.S. Food and Drug Administration (FDA), as of our Prescription Drug User Fee Act date on April 1 and through today.”
The company said that it received formal communication from the FDA in the form of an information request for a post-marketing commitment to generate additional clinical data.
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“We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible,” the company said in the SEC filing on Wednesday.
According to a media report in early April, the regulators missed the deadline for deciding to grant full approval to Novavax’s shot.
The Wall Street Journal reports that the agency is now delaying the decision and has reportedly requested more data, making it unlikely that the application will be approved soon, according to sources.
In April, Novavax released preliminary results from the SHIELD-Utah study investigating the effects of systemic and local reactogenicity of COVID-19 vaccine doses in Utah.
SHIELD-Utah was a prospective, interventional study conducted at the University of Utah Health.
The study 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 Inc (NYSE:PFE)-BioNTech SE's (NASDAQ:BNTX) mRNA 2024-2025 vaccine.
In September 2024, the U.S. Food And Drug Administration (FDA) granted Emergency Use Authorization to Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) for active immunization to prevent COVID-19 in individuals aged 12 and older.
Novavax’s vaccine was included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.
Novavax Stock Prediction For 2025
Equity research analysts, both on and off Wall Street, typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.
Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at Novavax, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line.
For Novavax, the 200-day moving average sits at $9.94, according to Benzinga Pro, which is above the current price of $7.33. For more on charts and trend lines, see a description here.
Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.
Price Action: NVAX stock was up 19.5% at $7.47 on Wednesday.
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