Valneva SE Withdraws IXCHIQ Vaccine Applications Following FDA License Suspension
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
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Source: NASDAQ.COM
- Application Withdrawal: Valneva SE has voluntarily withdrawn its biologics license and IND applications for the IXCHIQ vaccine in the U.S. following the FDA's suspension of the vaccine's license in August 2025, indicating significant regulatory hurdles for the company.
- Clinical Trials Halted: Currently, no clinical studies for IXCHIQ are actively recruiting participants due to the FDA placing the IND on clinical hold, which disrupts the company's research and development timeline.
- Adverse Event Investigation: The FDA is investigating a serious adverse event plausibly related to IXCHIQ vaccination that occurred outside the U.S., involving a young adult who received three vaccines, which may undermine market confidence in the vaccine's safety.
- Commitment to Safety: Valneva emphasizes its commitment to the highest safety standards and continues proactive engagement with health authorities, asserting that IXCHIQ's benefit-risk profile remains favorable for individuals in endemic regions despite the current challenges.
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Analyst Views on VALN
Wall Street analysts forecast VALN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for VALN is 10.28 USD with a low forecast of 7.55 USD and a high forecast of 13.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
1 Buy
1 Hold
0 Sell
Moderate Buy
Current: 9.410
Low
7.55
Averages
10.28
High
13.00
Current: 9.410
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 Withdraws Ixchiq Vaccine Applications Amid FDA Hold
- Application Withdrawal: Valneva SE has voluntarily withdrawn its Biologics License Application (BLA) and Investigational New Drug (IND) application for the Ixchiq vaccine in the U.S. following the FDA's suspension of the license in August 2025 due to four reports of serious adverse events (SAEs) resembling chikungunya illness.
- Clinical Hold: The FDA has placed the IND for Ixchiq on clinical hold pending an investigation into a newly reported foreign SAE, resulting in no active clinical studies vaccinating participants, which significantly impacts the company's vaccine rollout strategy.
- Safety Assessment: Valneva is actively seeking additional information to further characterize the case related to Ixchiq vaccination, as the case may be plausibly linked to the vaccine, although causality has not been established, potentially affecting public confidence and market acceptance of the vaccine.
- Future Plans: Despite these challenges, Valneva intends to continue discussions with health authorities in all territories where Ixchiq is licensed and plans to advance post-marketing clinical activities, while also looking forward to submitting a Biologics License Application for the Lyme disease vaccine candidate VLA15 in collaboration with Pfizer in 2026.
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Valneva SE Withdraws Chikungunya Vaccine Applications, Shares Drop 7.7%
- Vaccine Withdrawal: Valneva SE has withdrawn its BLA and IND applications for the IXCHIQ Chikungunya vaccine due to an FDA suspension and review of new serious adverse events, leading to a 7.7% drop in pre-market trading to $9.29, indicating market concerns over its product prospects.
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