Valneva SE Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Valneva SE (VALN).

If you purchased Valneva SE securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Valneva SE

Valneva SE is a specialty vaccine company focused on developing and commercializing vaccines for infectious diseases. The company’s portfolio includes vaccines targeting diseases such as chikungunya, Lyme disease, and shigella.

Valneva SE’s flagship product, IXCHIQ, is the first chikungunya vaccine to be approved in both the United States and Europe.

Potential Concerns Under Investigation

Lawyers are investigating whether Valneva SE may have made misleading statements or omitted important information regarding the safety and regulatory status of its chikungunya vaccine, IXCHIQ.

On Aug. 25, 2025, Valneva SE announced that the U.S. FDA had immediately suspended the license for IXCHIQ due to four serious adverse events that mirrored chikungunya symptoms. Following this announcement, VALN shares plunged approximately 22%, dropping from about $11.70 to $9.12 in a single trading day, wiping out tens of millions in shareholder value.

Attorneys may examine whether Valneva SE’s public statements prior to this event accurately reflected the growing safety concerns.

For example, on May 7, 2025, the company “confirmed" its 2025 financial guidance, which may have implied no material adverse changes to its outlook, despite emerging reports of severe vaccine reactions.

Similarly, in its Aug. 12, 2025 half-year report, Valneva SE again “confirmed" its 2025 guidance, even as internal issues with the vaccine program were escalating. Lawyers may investigate whether these reassurances were materially misleading in light of the known risks.

Another area of concern is an Aug. 12, 2025 management update, where Valneva SE asserted that the FDA and European Medicines Agency had lifted usage restrictions on IXCHIQ for older adults. In fact, the FDA suspended the vaccine’s U.S. license just weeks later.

Lawyers may examine whether this statement was accurate and whether investors were misled by the company’s claims. Legal professionals might also review whether Valneva SE adequately disclosed the extent of safety concerns.

While the company began acknowledging safety issues in early 2025, including regulatory cautions from the CDC, France, and the EMA, management appeared to downplay these as “precautionary” and highlighted only one death in a qualified manner.

At the same time, Valneva SE touted “double-digit sales growth” and strong emergency use cases, without fully informing investors about the alleged regulatory probes and adverse events.

The investigation may also focus on whether Valneva SE’s CEO and board members were aware of the mounting serious adverse events, including fatal cases, and whether they continued to promote the vaccine’s safety profile while not fully disclosing the extent of the issues.

Regulatory agencies in France, the United States, and Europe placed temporary age restrictions on IXCHIQ in April and May 2025, and Valneva SE acknowledged these actions.

The legal claims that lawyers may examine include potential violations of Section 10(b) and Rule 10b-5 of the Securities Exchange Act, focusing on alleged material misrepresentations or omissions in Valneva SE’s public statements and filings.

The proposed class period for this investigation is from May 7, 2025, to Aug. 24, 2025. This period covers the timeframe in which lawyers may allege that investors purchased Valneva SE securities at prices inflated by potentially misleading statements and omissions.

Your Rights and Next Steps

Investors who purchased Valneva SE securities between May 7, 2025, and Aug. 24, 2025, and suffered financial losses may have important legal rights. This is currently an investigation, not a filed lawsuit. However, if enough evidence is gathered, it could lead to a securities class action lawsuit seeking compensation for affected investors.

Lawyers are ready to help investors understand their options. If you meet the class period criteria and experienced losses, you may be eligible to participate in any future class action that may result from this investigation. Investors are encouraged to gather their transaction records and stay informed as the investigation progresses.

You May Be Entitled to Compensation

Securities investigations are time-sensitive. If you purchased Valneva SE securities and suffered losses during the proposed class period, you may be entitled to compensation if a class action is filed and succeeds.

To protect your rights and join the investigation, complete the form below.