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: 6.090
Low
7.55
Averages
10.28
High
13.00
Current: 6.090
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.
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- Vaccine Trial Results: Valneva and Pfizer's joint announcement regarding their 6-valent OspA-based vaccine failed to meet its primary endpoint in Phase 3 trials, raising market concerns despite the companies' positive characterization of the data due to low disease incidence.
- Stock Price Plunge: Following the trial results, Valneva's American Depositary Receipt (ADR) price fell by $3.83, a 37.11% drop, closing at $6.49, reflecting investor pessimism about the company's future prospects.
- Legal Implications: The investigation could lead to a class action lawsuit against Valneva, and if fraud is established, it may severely impact the company's financial health and reputation.
See More
Valneva SE Under Investigation for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating on behalf of Valneva SE investors regarding potential securities fraud or other unlawful business practices, indicating serious concerns about the company's governance and compliance.
- Vaccine Trial Results: Valneva's Phase 3 clinical trial for its 6-valent OspA-based Lyme disease vaccine failed to meet its primary endpoint, despite the company characterizing the data as positive, reflecting potential risks in product development.
- Stock Price Plunge: Following the trial results announcement, Valneva's American Depositary Receipt (ADR) price fell by $3.83, a 37.11% drop, closing at $6.49, demonstrating market pessimism regarding the company's outlook.
- Legal Implications: The investigation may lead to class action lawsuits against Valneva, with investors potentially seeking damages, further impacting the company's financial health and reputation.
See More
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- Investigation Launched: Pomerantz LLP is investigating whether Valneva SE has engaged in securities fraud or other unlawful business practices, aiming to protect investor rights and pursue legal accountability.
- Vaccine Trial Results: The Phase 3 clinical trial results for Valneva's 6-valent OspA-based Lyme disease vaccine, developed with Pfizer, were characterized as positive, yet failed to meet the primary endpoint, indicating potential efficacy issues.
- Stock Price Plunge: Following the announcement of the trial results, Valneva's American Depositary Receipt (ADR) price fell by $3.83, a 37.11% drop, closing at $6.49, reflecting market concerns about its future prospects.
- Legal Implications: This investigation may lead to class action lawsuits against Valneva, prompting investors to stay informed about developments to take timely action to protect their interests.
See More
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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.
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See More
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- 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 SE Under Investigation for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating whether Valneva SE has engaged in securities fraud or other unlawful business practices, aiming to protect investor rights and potentially exposing the company to legal liabilities.
- Vaccine Trial Results: Valneva and Pfizer's joint announcement regarding their 6-valent OspA-based vaccine failed to meet its primary endpoint in Phase 3 trials, raising market concerns despite the companies' positive characterization of the data due to low disease incidence.
- Stock Price Plunge: Following the trial results, Valneva's American Depositary Receipt (ADR) price fell by $3.83, a 37.11% drop, closing at $6.49, reflecting investor pessimism about the company's future prospects.
- Legal Implications: The investigation could lead to a class action lawsuit against Valneva, and if fraud is established, it may severely impact the company's financial health and reputation.
See More
Valneva SE Under Investigation for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating on behalf of Valneva SE investors regarding potential securities fraud or other unlawful business practices, indicating serious concerns about the company's governance and compliance.
- Vaccine Trial Results: Valneva's Phase 3 clinical trial for its 6-valent OspA-based Lyme disease vaccine failed to meet its primary endpoint, despite the company characterizing the data as positive, reflecting potential risks in product development.
- Stock Price Plunge: Following the trial results announcement, Valneva's American Depositary Receipt (ADR) price fell by $3.83, a 37.11% drop, closing at $6.49, demonstrating market pessimism regarding the company's outlook.
- Legal Implications: The investigation may lead to class action lawsuits against Valneva, with investors potentially seeking damages, further impacting the company's financial health and reputation.
See More
Pomerantz LLP Investigates Valneva for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating whether Valneva SE has engaged in securities fraud or other unlawful business practices, aiming to protect investor rights and pursue legal accountability.
- Vaccine Trial Results: The Phase 3 clinical trial results for Valneva's 6-valent OspA-based Lyme disease vaccine, developed with Pfizer, were characterized as positive, yet failed to meet the primary endpoint, indicating potential efficacy issues.
- Stock Price Plunge: Following the announcement of the trial results, Valneva's American Depositary Receipt (ADR) price fell by $3.83, a 37.11% drop, closing at $6.49, reflecting market concerns about its future prospects.
- Legal Implications: This investigation may lead to class action lawsuits against Valneva, prompting investors to stay informed about developments to take timely action to protect their interests.
See More
Biotech Landscape Update: Regulatory Approvals and Mergers
- Anavex Drug Withdrawal: Anavex Life Sciences Corp. (AVXL) withdrew its EU marketing application for Alzheimer's drug Blarcamesine after the EMA's CHMP indicated it could not issue a positive opinion, marking a significant setback for the company's lead candidate despite continued support from patient groups.
- Quoin FDA Alignment: Quoin Pharmaceuticals Ltd. (QNRX) received positive feedback from the FDA confirming that a single Phase 3 trial may suffice for U.S. approval of QRX003 for Netherton Syndrome, with plans to initiate Phase 3 in 2026 and potentially file an NDA in 2027.
- Corcept Drug Approval: Corcept Therapeutics Inc. (CORT) secured FDA approval for Lifyorli combined with nab-paclitaxel to treat platinum-resistant ovarian cancer, based on Phase 3 ROSELLA trial results involving 381 patients, marking the first FDA-approved selective glucocorticoid receptor antagonist.
- Merck Acquires Terns: Merck (MRK) announced a definitive agreement to acquire Terns Pharmaceuticals for $53.00 per share, totaling approximately $6.7 billion, which is expected to enhance Merck's presence in hematology, with the transaction anticipated to close in Q2 2026.
See More
Valneva to Participate in World Vaccine Congress 2026
- 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
