Why Did VALN Stock Surge 24% Today?

The European Medicines Agency validated the marketing authorization application for Valneva’s Lyme disease vaccine, which it developed with Pfizer

• The validation means the application can now undergo a formal scientific assessment in the European Union.
• PF-07307405 is the most advanced Lyme disease vaccine candidate, with no human vaccine approved to date, according to Pfizer.
• The application is supported by the Phase 3 Valor trial completed earlier this year.

Shares of Valneva (VALN) stock surged 24% on Friday after the European Medicines Agency accepted the marketing application for its experimental Lyme disease vaccine for review.

Valneva developed the vaccine in partnership with Pfizer (PFE). If it receives regulatory approval, Pfizer will have exclusive rights to manufacture and commercialize it.

VALN stock recorded its biggest single-day gains since June 2022, and is currently trading at its highest levels since March. PFE shares edged 0.2% lower.

A Step Closer To The First Approved Lyme Disease Vaccine

The validation means the application can now undergo a formal scientific assessment, a crucial step ahead of launch across the European Union. However, it does not indicate that the vaccine, known as PF-07307405, will ultimately be approved.

Lyme disease is a bacterial infection that can cause rashes, joint aches, fatigue and nerve issues. PF-07307405 is the most advanced Lyme disease vaccine candidate, and no human vaccine has been approved to date, according to Pfizer.

“Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart,” said Annaliesa Anderson, Senior Vice President and Chief Vaccines Officer at Pfizer.

Application Supported By Trial Involving More Than 9,000 Participants

The application is supported by the Phase 3 Valor trial completed earlier this year. The trial tested the vaccine in 9,437 people aged five and older across Lyme-endemic regions in the U.S., Canada and Europe. The vaccine was well tolerated, with no safety concerns identified during the analysis.

However, the primary analysis failed to meet its predetermined statistical requirement because fewer Lyme disease cases occurred than expected. Pfizer has argued that the overall efficacy was clinically meaningful.

Retail Says VALN Could Climb To $20

Retail sentiment surrounding VALN on Stocktwits flipped to ‘extremely bullish’ from ‘bearish’ over the past 24 hours, amid ‘extremely high’ message volumes.

One user said the stock could fly to $20 if it broke the resistance at $8. It is currently trading at around $7.

View this Stocktwits post

VALN shares have declined more than 20% so far this year.

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