Valneva Voluntarily Withdraws Ixchiq Vaccine Applications
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 19 2026
0mins
Should l Buy VALN?
Valneva SE announced that the company has decided to voluntarily withdraw the biologics license application, BLA, and Investigational New Drug, IND, application for its chikungunya vaccine, Ixchiq, in the United States, following suspension of the license by the U.S. Food and Drug Administration, FDA, in August 2025. The Company had been awaiting further information with respect to its formal response to the vaccine license suspension. Valneva was recently informed of the FDA's further decision to now place the Investigational New Drug, IND, on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event, SAE. There are currently no clinical studies involving Ixchiq that are actively vaccinating participants, and the Company intends to move forward with its planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.
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Analyst Views on VALN
Wall Street analysts forecast VALN stock price to rise
2 Analyst Rating
1 Buy
1 Hold
0 Sell
Moderate Buy
Current: 6.480
Low
7.55
Averages
10.28
High
13.00
Current: 6.480
Low
7.55
Averages
10.28
High
13.00
About VALN
Valneva SE is a France-based company that specializes in the development, manufacture and commercialization of vaccines to protect people from infectious diseases through preventative medicine. The Company's portfolio includes two commercial vaccines for travelers: IXIARO/JESPECT, for the prevention of Japanese Encephalitis, and DUKORAL, which is indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by Enterotoxigenic escherichia coli (ETEC). The Company has also vaccines in development, including candidates against Lyme disease, COVID-19 and chikungunya. Its technologies and services segment cooperates with various pharmaceutical companies using its platform: EB66 vaccine production cell line and IC31 adjuvant. The Company is focused on research and development (R&D) programs, as well as holds investment in product candidates and commercial products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Valneva to Participate in World Vaccine Congress 2026
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- Vaccine Campaign Launch: In collaboration with Instituto Butantan, Valneva has initiated a pilot vaccination campaign for its IXCHIQ® vaccine in Brazil, with over 12,000 individuals vaccinated, aimed at evaluating the vaccine's effectiveness and safety for post-marketing commitment studies.
- Academic Engagement: On April 1, 2026, at 9:40 am EST, Valneva's Vice President of Clinical Development, Susanne Eder-Lingelbach, will present updates on chikungunya vaccine development, enhancing the company's academic influence in the vaccine sector.
- Strategic Partnership Expansion: Valneva will leverage the congress to meet with current and potential partners, demonstrating its strengths in vaccine development and commercialization, thereby furthering its global market expansion efforts.
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- Legal Investigation Initiated: Pomerantz LLP is investigating whether Valneva and its executives engaged in securities fraud or other unlawful business practices, advising investors to contact them for more information, indicating a potential loss of confidence in the company's governance.
- Historical Context: Pomerantz LLP, recognized as a leading firm in securities class action litigation with over 85 years of experience, focuses on fighting for the rights of victims of securities fraud, suggesting that this incident may lead to broader legal ramifications.
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- Vaccine Development Outlook: Despite the disappointing trial results, Pfizer remains confident in the vaccine's potential and plans to submit applications to regulatory authorities in the U.S. and EU, indicating a long-term commitment to the vaccine market.
- Global Health Impact: Lyme disease is the most common tick-borne illness globally, with research in 2022 estimating that over 14% of the global population has been infected, and the potential increase in transmission rates due to climate change underscores the critical need for vaccine development.
See More
Pfizer and Valneva Report Phase 3 Results for Lyme Disease Vaccine
- Vaccine Efficacy: Pfizer and Valneva's Lyme disease vaccine candidate PF-07307405 demonstrated over 70% efficacy in individuals aged five and older, significantly boosting confidence in its potential to change Lyme disease prevention strategies.
- Safety Assessment: The investigational vaccine was well tolerated with no safety concerns identified during the analysis, laying a solid foundation for future regulatory submissions and indicating its feasibility for clinical use.
- Market Demand: Lyme disease can lead to serious consequences that disrupt daily life, work, and long-term health, and with no available vaccine currently, the development of this vaccine holds significant market importance.
- Regulatory Plans: Pfizer is planning submissions to regulatory authorities to advance the vaccine's market entry, reflecting the company's confidence in the candidate and its potential impact on public health.
See More
Pfizer and Valneva Report Phase 3 Vaccine Trial Results
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- Statistical Criteria Not Met: Although the second pre-specified analysis showed an efficacy of 74.8%, the study accrued fewer Lyme disease cases than anticipated, resulting in the first analysis failing to meet the predetermined statistical criteria, which may impact the vaccine's market prospects.
- Regulatory Submission Plans: Pfizer is planning to submit applications to regulatory authorities based on the results of the second analysis, despite the first analysis not meeting the criteria, as the lower bound of the 95% confidence interval exceeded 20, indicating the vaccine's potential value.
- Collaboration Agreement Context: Pfizer and Valneva entered into a collaboration and license agreement in April 2020 for the co-development of PF-07307405, with Pfizer responsible for its manufacturing and commercialization, establishing a strategic partnership that lays the groundwork for the vaccine's future development.
See More
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- Congress Participation: Valneva SE will participate in the World Vaccine Congress from March 31 to April 2, 2026, in Washington D.C., with CEO Thomas Lingelbach leading a team of senior executives, showcasing the company's leadership in vaccine development.
- Vaccine Campaign Launch: In collaboration with Instituto Butantan, Valneva has initiated a pilot vaccination campaign for its IXCHIQ® vaccine in Brazil, with over 12,000 individuals vaccinated, aimed at evaluating the vaccine's effectiveness and safety for post-marketing commitment studies.
- Academic Engagement: On April 1, 2026, at 9:40 am EST, Valneva's Vice President of Clinical Development, Susanne Eder-Lingelbach, will present updates on chikungunya vaccine development, enhancing the company's academic influence in the vaccine sector.
- Strategic Partnership Expansion: Valneva will leverage the congress to meet with current and potential partners, demonstrating its strengths in vaccine development and commercialization, thereby furthering its global market expansion efforts.
See More
Valneva's Vaccine Trial Fails to Meet Primary Endpoint
- Vaccine Trial Results: Valneva and Pfizer's investigational 6-valent OspA-based Lyme disease vaccine PF-07307405 (LB6V) failed to meet its primary endpoint in the Phase 3 VALOR clinical trial, with the companies characterizing the data as positive despite a low incidence of disease cases.
- Stock Price Plunge: Following the trial results announcement, Valneva's American Depositary Receipt (ADR) price fell by $3.83, or 37.11%, closing at $6.49, reflecting strong market concerns regarding the vaccine's prospects.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Valneva and its executives engaged in securities fraud or other unlawful business practices, advising investors to contact them for more information, indicating a potential loss of confidence in the company's governance.
- Historical Context: Pomerantz LLP, recognized as a leading firm in securities class action litigation with over 85 years of experience, focuses on fighting for the rights of victims of securities fraud, suggesting that this incident may lead to broader legal ramifications.
See More
Valneva's Lyme Disease Vaccine Candidate Shows Over 70% Efficacy
- Significant Vaccine Efficacy: Valneva's Lyme disease vaccine candidate, developed in partnership with Pfizer, demonstrated over 70% efficacy in a large Phase 3 study, although it failed to meet the statistical threshold for the primary endpoint due to lower-than-expected case numbers, still providing confidence in the vaccine's potential.
- Strong Safety Profile: The vaccine was well tolerated with no safety concerns identified during the analysis, and Pfizer's Chief Vaccines Officer Annaliesa Anderson described the results as 'highly encouraging,' emphasizing the critical need for a preventive option for Lyme disease, indicating its strategic importance in the market.
- Robust Financial Position: Valneva reported €109.7 million in cash and cash equivalents at the end of 2025, with expectations of further declines in operating cash burn in 2026 while still supporting strategic R&D investments, showcasing the company's focus on financial management.
- Market Reaction Volatility: Despite the vaccine's strong efficacy, Valneva's stock closed down 1.67% on March 20, 2026, and fell 35.08% in pre-market trading, reflecting a cautious market sentiment regarding the vaccine's potential.
See More
Experimental Lyme Disease Vaccine Shows Over 70% Efficacy
- Vaccine Efficacy: Pfizer and Valneva announced that their experimental Lyme disease vaccine demonstrated over 70% efficacy in individuals aged five and older, although the clinical trial did not meet its primary endpoint, indicating both potential and market risks.
- Clinical Trial Results: The trial failed to meet its primary endpoint due to fewer Lyme disease cases than expected during the study period, which directly impacted Valneva's stock price, plunging over 38% on the Paris stock exchange, highlighting market sensitivity to clinical outcomes.
- Vaccine Development Outlook: Despite the disappointing trial results, Pfizer remains confident in the vaccine's potential and plans to submit applications to regulatory authorities in the U.S. and EU, indicating a long-term commitment to the vaccine market.
- Global Health Impact: Lyme disease is the most common tick-borne illness globally, with research in 2022 estimating that over 14% of the global population has been infected, and the potential increase in transmission rates due to climate change underscores the critical need for vaccine development.
See More
Pfizer and Valneva Report Phase 3 Results for Lyme Disease Vaccine
- Vaccine Efficacy: Pfizer and Valneva's Lyme disease vaccine candidate PF-07307405 demonstrated over 70% efficacy in individuals aged five and older, significantly boosting confidence in its potential to change Lyme disease prevention strategies.
- Safety Assessment: The investigational vaccine was well tolerated with no safety concerns identified during the analysis, laying a solid foundation for future regulatory submissions and indicating its feasibility for clinical use.
- Market Demand: Lyme disease can lead to serious consequences that disrupt daily life, work, and long-term health, and with no available vaccine currently, the development of this vaccine holds significant market importance.
- Regulatory Plans: Pfizer is planning submissions to regulatory authorities to advance the vaccine's market entry, reflecting the company's confidence in the candidate and its potential impact on public health.
See More
Pfizer and Valneva Report Phase 3 Vaccine Trial Results
- Vaccine Efficacy Results: Pfizer and Valneva's Phase 3 trial of the 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 demonstrated an efficacy of 73.2% in reducing confirmed Lyme disease cases from 28 days post-dose 4, indicating significant clinical relevance in preventing Lyme disease.
- Statistical Criteria Not Met: Although the second pre-specified analysis showed an efficacy of 74.8%, the study accrued fewer Lyme disease cases than anticipated, resulting in the first analysis failing to meet the predetermined statistical criteria, which may impact the vaccine's market prospects.
- Regulatory Submission Plans: Pfizer is planning to submit applications to regulatory authorities based on the results of the second analysis, despite the first analysis not meeting the criteria, as the lower bound of the 95% confidence interval exceeded 20, indicating the vaccine's potential value.
- Collaboration Agreement Context: Pfizer and Valneva entered into a collaboration and license agreement in April 2020 for the co-development of PF-07307405, with Pfizer responsible for its manufacturing and commercialization, establishing a strategic partnership that lays the groundwork for the vaccine's future development.
See More
