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Valneva SE

Valneva SE, a specialty vaccine company, develops, manufactures, and commercializes prophylactic vaccines for infectious diseases with unmet needs. It offers IXIARO, an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis; DUKORAL, an oral vaccine for the prevention of diarrhea caused by Vibrio cholera or heat-labile toxin producing enterotoxigenic Escherichia coli bacterium; and IXCHIQ/ VLA1553, a single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus. The company also develops VLA15, a vaccine candidate against Borrelia, the bacterium that causes Lyme disease; S4V2, a tetravalent bioconjugate vaccine candidate against shigellosis, a diarrheal infection caused by Shigella bacteria; VLA1601, a vaccine candidate targeting the Zika virus, a mosquito-borne viral disease; VLA1554, a vaccine candidate targeting human metapneumovirus; VLA84, a vaccine candidate targeting the prevention of primary symptomatic clostridium difficile infection; PF-07307405, a vaccine candidate to prevent Lyme disease cases in individuals aged five years and older and VLA2112, a vaccine candidate to treat patients with epstein-barr virus. It sells its products in the United States, Canada, Germany, Austria, Nordics, the United Kingdom, France, rest of Europe, and internationally. Valneva SE was founded in 1998 and is based in Saint-Herblain, France.

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Biotech & Genomic Medicine▲

Pfizer and Valneva Start EMA Review for Lyme Disease Vaccine

Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for their Lyme disease vaccine candidate, PF-07307405, initiating the regulatory assessment process for what could become a first-in-class vaccine for the disease in North America and Europe. The application is backed by Phase 3 efficacy data, with the companies highlighting an unmet medical need in Lyme disease prevention. This development is part of Pfizer's broader strategy to address widespread infectious diseases, complementing its existing vaccine portfolio. Investors should monitor the EMA's review milestones, including committee opinions and formal decisions expected into 2027, as well as any disclosures on manufacturing readiness and uptake expectations for the vaccine.
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Pfizer and Valneva Lyme Disease Vaccine Application Validated by EMA

The European Medicines Agency has validated the Marketing Authorization Application for Pfizer and Valneva's Lyme disease vaccine candidate PF-07307405, beginning its assessment of the submission. The application is based on efficacy of more than 70% observed in the Phase 3 VALOR trial, which enrolled 9,437 participants aged five and older across the U.S., Canada, and Europe, with no safety concerns identified. Pfizer's Chief Vaccines Officer Annaliesa Anderson said the vaccine could be the first of its kind in Europe, where Lyme disease affects more than 100,000 people annually and over 200 million live in risk areas. Valneva CEO Thomas Lingelbach called the acceptance a major milestone for the collaboration established in April 2020, under which Pfizer will exclusively manufacture and commercialize the vaccine if approved.
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Valneva Reports First Half 2026 Results and Reaffirms Guidance

Valneva SE reported first half 2026 financial results with total product sales of €64.0 million and reaffirmed its full-year guidance of €135 to €150 million in product sales. The company posted a net loss of €63.3 million for the six months ended June 30, 2026, compared with a net loss of €20.8 million in the same period of 2025, reflecting lower gross margin due to lower sales and manufacturing volumes as well as one-off impacts on cost of goods sold, including IXCHIQ-related contract termination costs and inventory write-offs. Valneva's cash position stood at €121.5 million as of end June 2026, up from €109.7 million at December 31, 2025, supported by disciplined cash management and €37 million in gross proceeds from a reserved offering completed in the second quarter. The company also implemented a global restructuring program expected to have positive profit and loss and cash flow impacts in the second half of the year and beyond, including a workforce reduction and the agreed sale of its Nantes site in France for €6.2 million. Regulatory decisions for the Lyme disease vaccine candidate LB6V, partnered with Pfizer, are expected in the next twelve months, with Pfizer expressing optimism about obtaining registration.
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Valneva shareholders approve all AGM resolutions, Dr. Gerd Zettlmeissl appointed Chair

Valneva SE announced that shareholders approved all resolutions recommended by the Board of Directors at its Annual General Meeting held in Lyon, France. Key resolutions included approval of the 2025 financial statements, renewal of share capital authorizations, and the transfer of the registered office to Lyon. Shareholders also reappointed five Board members: Anne-Marie Graffin, James Sulat, and Kathrin Jansen for one-year terms, James Connelly for a two-year term, and CEO Thomas Lingelbach for a three-year term. Following the meeting, the Board appointed independent director Dr. Gerd Zettlmeissl as Chair, succeeding Anne-Marie Graffin, who will continue as Vice-chair.
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