Valneva SE (VALN)

H.C. Wainwright analyst Brandon Folkes assumed coverage of Valneva with a Buy rating and $18 price target. The firm says Valneva is a commercial-stage vaccine company with a "strong proprietary portfolio." VLA15 offers a "de-risked, relatively high-probability path" to potential blockbuster sales, the analyst tells investors in a research note.

Saint Herblain (France), August 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. This announcement adds to the adult marketing authorization already received in Canada 1 and complements the adolescent label extension received in Europe in April 20252.

Valneva SE (NASDAQ:VALN ) Q2 2025 Earnings Conference Call August 12, 2025 9:00 AM ET Company Participants Joshua Drumm - Vice President of Investor Relations Peter Buhler - Chief Financial Officer Thomas Lingelbach - President, CEO & Director Conference Call Participants Damien Choplain - Stifel, formerly Bryan Garnier & Co., Research Division Mohamad Amin Makarem - Jefferies LLC, Research Division Rajan Sharma - Goldman Sachs Group, Inc., Research Division Sebastiaan van der Schoot - Unidentified Company Joshua Drumm Thank you, operator. Hello, and thank you for joining us to discuss Valneva's first half 2025 results and corporate update.

Saint-Herblain (France), August 12, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year, ended June 30, 2025, and confirmed its 2025 financial guidance. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company's website (Financial Reports – Valneva).

Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ®. IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.

SEATTLE & HEIDELBERG, Germany--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) to supply drug substance for an investigational four-valent Shigella bioconjugate vaccine at the CDMO's Heidelberg facility. Valneva exclusively licensed the vaccine candidate from LimmaTech Biologics AG, which previously worked with AGC Biologics to establish GMP.

Valneva (VALN) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva's single-dose chikungunya vaccine IXCHIQ® by EMA's safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people with several underlying medical conditions.

The European Union's health regulator has lifted the temporary restriction on the use of French drugmaker Valneva's chikungunya vaccine, Ixchiq, in adults aged 65 and above, following a safety review.

Saint-Herblain, France, June 26, 2025 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an exclusive agreement with CSL Seqirus, one of the world's largest influenza vaccine companies, for the marketing and distribution of Valneva's three proprietary vaccines in Germany.

Saint-Herblain (France), June 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Annual General Meeting held today in Lyon, France.

UK's medicine regulator said on Monday it has temporarily restricted the use of French vaccine maker Valneva's shot to treat chikungunya, a virus transmitted by mosquitoes, in people aged 65 and above as a precautionary measure.

Saint-Herblain (France), June 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the first quarter of 2026, with the objective of extending the product label to this age group.

Saint-Herblain (France), June 4, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Combined General Meeting (“the Meeting”) to be held on June 25, 2025 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France).

Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025.

Saint Herblain (France), May, 12 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Association (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), in a joint communication to the medical community, have recommended a pause in the use of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of IXCHIQ® in persons aged 65 and over and a similar decision by the European Medicines Agency (EMA) to temporarily suspend the use of the vaccine for individuals over 65 years old pending investigation.