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ALLISON GATLIN

Novavax, With A 369% Gain, Reverses Bullish Gains After Key FDA Move

Novavax stock zipped higher Thursday — and then gave it all up — after the Food and Drug Administration set a potential approval date for its Covid vaccine in April.

In a filing with the Securities and Exchange Commission, Novavax said the FDA said it completed its filing review of the final portion of its request for approval. The agency is set to make its decision in April 2025.

The news initially sent Novavax stock as high as 13%. But Novavax shares closed down 6.8% at 19.56.

On Wednesday, Novavax said it plans to launch an updated booster to target the JN.1 variant, in line with the FDA Vaccines and Related Biological Products Advisory Committee's recommendation. Pfizer and Moderna are also planning to prepare JN.1-focused boosters.

Novavax stock has been on a tear recently, surging 369% from dollar-stock status on May 9 to the closing price of 20.97 on Wednesday. Shares now have a perfect IBD Digital Relative Strength Rating of 99 and opened at their highest point since November 2022. The RS Rating is a 1-99 measure of a stock's 12-month performance.

Novavax Stock: Reversing Its Fortunes

Novavax's Covid vaccine has faced a number of setbacks over the years. The vaccine is based on protein technology, which is appealing to people hesitant to use the newer messenger RNA-based shots from Pfizer with partner BioNTech and Moderna.

But the Novavax Covid vaccine has never been officially approved. Instead, the company has racked up sales under an emergency use authorization. Last September, the FDA approved updated boosters from Pfizer and Moderna, but didn't authorize Novavax's shot until October.

Recent news, though, has set Novavax stock on a sprint. Shares skyrocketed more than 125% on May 10 after the company inked a licensing deal with Sanofi for its Covid vaccine. Sanofi will pay Novavax $500 million up front. Milestone, regulatory and other payments could add $700 million.

The companies also agreed to co-develop a Covid/flu vaccine. Sanofi will co-commercialize it worldwide.

Since then. Novavax stock has continued climbing. Shares easily retook their 50-day and 200-day moving averages, MarketSurge shows. Notably, Novavax shares now have an improved Composite Rating of 89, putting their technical and fundamental performance in the leading 11% of all stocks.

Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.

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