synopsis

The company announced on Wednesday that it had received formal communication from the FDA in the form of an information request for a “postmarketing commitment” to generate additional clinical data.

Shares of Novavax Inc. (NVAX) traded 20% higher on Wednesday morning after the company expressed optimism about receiving traditional approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine despite delays.

The protein-based vaccination was previously cleared for emergency use. The FDA had set April 1 as the deadline to decide whether to grant it a normal, full approval, allowing for its continued use, similar to the messenger RNA-based COVID-19 shots from Pfizer and Moderna.

However, the agency missed the deadline, creating doubts about the approval.

The company stated on Wednesday that it had received formal communication from the FDA in the form of an information request for a “postmarketing commitment” to generate additional clinical data.

Postmarketing commitments refer to studies or clinical trials that a sponsor has agreed to conduct, but which are not required by statute or regulation. They are conducted after approval to gather additional information about a product's safety, efficacy, or optimal use.

“We believe that our Biologics License Application (BLA) is approvable based on conversations with the U.S. Food and Drug Administration (FDA),” the company said.

Novavax added that it looks forward to engaging with the FDA “expeditiously” to address the postmarketing commitment request and move to approval “as soon as possible.”

On Stocktwits, however, retail sentiment around Novavax fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours while message volume fell from ‘normal’ to ‘low’ levels.

NVAX's Sentiment Meter and Message Volume as of 10:05 a.m. ET on April 23, 2025 | Source: Stocktwits

NVAX stock is down by about 12% this year, but gained over 79% in the past 12 months.

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