Valneva SE (VALN) Valneva SE operates as a specialized biopharmaceutical company, concentrating its efforts on developing and bringing to market preventative vaccines for infectious diseases where current medical options are insufficient. Its portfolio of commercial travel vaccines includes IXIARO, an inactivated vaccine derived from Vero cell culture, which provides active immunity against Japanese encephalitis. Another offering is DUKORAL, an oral vaccine designed to guard against diarrhea induced by Vibrio cholerae or enterotoxigenic Escherichia coli (ETEC) bacteria. The company's development pipeline features VLA2001, a candidate vaccine targeting SARS-CoV-2. Additionally, Valneva is progressing with VLA15, a Lyme disease vaccine candidate that has successfully concluded Phase II clinical trials and is being co-developed and commercialized with Pfizer, Inc. They are also advancing VLA1553, a chikungunya virus vaccine candidate currently undergoing Phase III clinical evaluation, in partnership with Instituto Butantan for its development, production, and marketing as a single-shot vaccine. Valneva's products are sold across a wide geographical area, including the United States, Canada, Germany, Austria, the Nordic countries, the United Kingdom, various other European nations, and internationally. Founded in 1998, the company maintains its headquarters in Saint-Herblain, France.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Valneva SE NASDAQ:VALN Healthcare · Biotechnology
Mkt Cap $516.79M
Vol 0
$ Vol 0
RVOL 0
Earnings 0
Press Release ⚠ 1
Valneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare Conferences
Valneva announced senior management will present and hold investor meetings at four U.S. and European healthcare conferences between October 15 and November 16, 2026.
Fireside chats will focus on the regulatory outlook for its Pfizer-partnered Lyme disease vaccine candidate, with regulatory decisions expected within the next 12 months.
The release is a routine IR calendar notice with no new financial or clinical data; the forward-looking statements also reference the UK MHRA's revocation of the IXCHIQ marketing authorization as an ongoing risk area.
• 18d ago AI analysis › Press Release
REG-Valneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare Conferences
Valneva announced senior management will present at four upcoming healthcare conferences in the U.S. and Europe during October and November 2026.
The fireside chats will focus on the regulatory outlook for its Pfizer-partnered Lyme disease vaccine candidate, with regulatory decisions expected within the next 12 months.
The release is an administrative calendar notice with no new financial or clinical data; forward-looking statements reference the UK MHRA revocation of IXCHIQ's authorization previously disclosed.
• 18d ago AI analysis › Press Release ⚠ 2
Valneva Provides Update on IXCHIQ® in the United Kingdom
The UK's MHRA revoked the marketing authorization for Valneva's chikungunya vaccine IXCHIQ following a further benefit-risk assessment by the Commission on Human Medicines; the decision was based on prior safety data, with no newly identified safety signal.
Financial impact is minimal: Valneva had already stopped distributing IXCHIQ in the UK due to low traveler sales, expects no recall expense, and sees only minimal revenue impact going forward. Licenses in the EU, Canada, Brazil and other territories remain intact.
Valneva disagrees with the decision but will not appeal, prioritizing endemic-market expansion where over 61,000 people have been vaccinated in Brazil's pilot campaign with no new safety concerns; roughly 187,000 doses have been administered globally to date.
• 25d ago AI analysis › Press Release ⚠ 3
REG-Valneva Provides Update on IXCHIQ® in the United Kingdom
Valneva announced that the UK MHRA revoked the marketing authorization for its chikungunya vaccine IXCHIQ following a further benefit-risk assessment by the Commission on Human Medicines.
The decision was based on a review of previous safety data with no newly identified safety signal, and does not affect licenses in the EU, Canada, Brazil, or other territories. EMA and Health Canada recently maintained IXCHIQ authorizations with updated product information.
Financial impact appears limited: Valneva stopped actively distributing IXCHIQ in the UK months ago due to low traveler sales, expects no recall expense, and will not appeal. Supportive post-marketing data include more than 61,000 people vaccinated in Brazil's pilot campaign with no new safety concerns.
• 25d ago AI analysis › Press Release
Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency
Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, their co-developed Lyme disease vaccine candidate.
The application is supported by Phase 3 VALOR trial data showing more than 70% efficacy in preventing Lyme disease across 9,437 participants aged five and older.
EMA validation confirms the application's completeness and initiates the formal review process, advancing the potential for the vaccine's commercialization in Europe.
• 2mo ago AI analysis › Press Release
REG-Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency
Pfizer and partner Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, a Lyme disease vaccine candidate.
The application is supported by data from the Phase 3 VALOR trial, which demonstrated an efficacy of more than 70% in participants aged five years and older.
This validation initiates the EMA's assessment of the candidate, which aims to become the first approved vaccine for Lyme disease in Europe, a condition affecting over 100,000 people annually.
• 2mo ago AI analysis › Press Release ⚠ 3
Valneva Reports Half Year 2026 Financial Results and Provides Corporate Updates
Valneva reported H1 2026 total revenues of €65.8 million, down from €97.6 million in the prior year, with a net loss widening to €63.3 million driven by lower sales and one-off charges.
Despite the top-line decline, the company reaffirmed its full-year 2026 guidance and ended the period with a strong cash position of €121.5 million, bolstered by a recent capital raise.
Management is executing a global restructuring initiative to reduce cash burn, including workforce reductions and the sale of its Nantes site for €6.2 million, while Pfizer remains optimistic about obtaining regulatory approval for the Lyme disease vaccine candidate LB6V within the next twelve months.
• 2mo ago AI analysis › Press Release ⚠ 3
REG-Valneva Reports Half Year 2026 Financial Results and Provides Corporate Updates
Valneva reported H1 2026 total revenue of €65.8 million, down from €97.6 million in the prior year, with a net loss widening to €63.3 million.
Despite the decline, the company reaffirmed its full-year guidance for product sales of €135-150 million, driven by expected H2 shipments and improved gross margins.
Valneva implemented a restructuring program including workforce reductions and agreed to sell its Nantes site for €6.2 million, bolstering its cash position to €121.5 million.
• 2mo ago AI analysis › Press Release
Valneva to Report First Half 2026 Consolidated Financial Results on August 13, 2026
Valneva SE announced it will report its first half 2026 consolidated financial results on Thursday, August 13, 2026.
The company will host a live webcast beginning at 3 p.m. CET / 9 a.m. ET to discuss the results and provide a business update.
An archive of the webcast will be made available on the company’s website after the event concludes.
• 3mo ago AI analysis › Press Release
REG-Valneva to Report First Half 2026 Consolidated Financial Results on August 13, 2026
Valneva SE announced that it will report its first half 2026 consolidated financial results on Thursday, August 13, 2026.
The company will host a live webcast at 9 a.m. ET to discuss the financial results and provide a business update.
An archive of the webcast will be made available on the company's website after the event concludes.
• 3mo ago AI analysis › Press Release
Valneva to Participate at U.S. and European Investor Conferences in June
globenewswire.com • 5mo ago Press Release
Valneva to Report First Quarter 2026 Consolidated Financial Results on May 13, 2026
globenewswire.com • 5mo ago Press Release
Valneva Announces the Successful Completion of an €84 million Reserved Offering
globenewswire.com • 6mo ago 
