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 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: 9.330
Low
7.55
Averages
10.28
High
13.00
Current: 9.330
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 and Brazil Launch Pilot Chikungunya Vaccine Program
- Pilot Program Launch: Valneva and Instituto Butantan have initiated a pilot vaccination strategy for the IXCHIQ® vaccine, aiming to evaluate its effectiveness and safety in real-world settings, with plans to vaccinate over 500,000 adults aged 18 to 59.
- Vaccine Coverage Goals: The program targets a vaccine coverage rate of 20% to 40% across ten strategically selected municipalities, addressing public health needs as outlined by the Brazilian Ministry of Health to mitigate chikungunya transmission.
- Global Health Commitment: Valneva's Chief Medical Officer emphasized that this initiative underscores the company's commitment to global preparedness against chikungunya threats, with expectations to generate critical real-world data that reinforces the vaccine's public health value.
- Technology Transfer and Collaboration: Valneva signed a technology transfer agreement with Butantan in 2021, ensuring the vaccine's development and commercialization in Latin America, highlighting the strong collaboration between the two entities in addressing public health challenges.
See More
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.
See More
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.
- Market Decline: U.S. stock futures are broadly lower, with Dow futures falling around 700 points, reflecting investor caution regarding economic outlook, which may impact overall market sentiment and exacerbate volatility in other stocks.
- Other Stock Movements: Shares of Rezolve AI PLC and POET Technologies Inc fell 15% and 11.2% respectively in pre-market trading, indicating widespread investor apprehension towards tech stocks, potentially prompting a reassessment of risk appetite.
- Tesla Update: Tesla's stock fell 2.7% to $425.75 in pre-market trading, despite CEO Elon Musk confirming that vehicles equipped with the AI4 chip will achieve unsupervised autonomous driving, suggesting insufficient market confidence in the electric vehicle sector.
See More
Valneva SE Withdraws IXCHIQ Vaccine Applications Following FDA License Suspension
- 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.
See More
Valneva Withdraws IXCHIQ Vaccine Applications Following FDA Suspension
- Application Withdrawal: Valneva SE has voluntarily withdrawn its biologics license application (BLA) and Investigational New Drug (IND) application for IXCHIQ® in the U.S. following the FDA's suspension in August 2025, highlighting the challenging regulatory landscape.
- Clinical Study Halt: With the FDA placing the IND for IXCHIQ® on clinical hold, Valneva currently has no active clinical studies recruiting participants, which will directly impact the vaccine's market rollout and future revenue expectations.
- Adverse Event Investigation: The hold is linked to a serious adverse event (SAE) reported abroad involving a young adult who received IXCHIQ®, prompting Valneva to actively seek additional information to assess the vaccine's safety, potentially affecting public confidence.
- Market Opportunity Assessment: While IXCHIQ® still has demand among travelers in endemic tropical and subtropical regions, Valneva must engage in further discussions with regulatory authorities to ensure the vaccine's commercial attractiveness aligns with medical needs, influencing its future strategic direction.
See More
Valneva to Showcase Vaccine Progress at J.P. Morgan Conference
- Management Meetings: Valneva SE will engage in one-on-one meetings with existing shareholders during the 44th Annual J.P. Morgan Healthcare Conference from January 12-14, 2026, aiming to strengthen ties with institutional investors and boost market confidence.
- Clinical Progress Discussion: CEO Thomas Lingelbach and CFO Peter Bühler will discuss upcoming pivotal data from the clinical development pipeline, including the Lyme disease vaccine, expected to be released in the first half of this year, which could positively impact future revenues.
- Vaccine Portfolio Showcase: Valneva will highlight its commercial vaccine portfolio, emphasizing its expertise in addressing unmet medical needs, particularly the Lyme disease vaccine candidate partnered with Pfizer, which may open new revenue streams for the company.
- Investor Relations Enhancement: The company encourages institutional investors to schedule meetings through its investor relations department, demonstrating Valneva's commitment to transparency and investor communication, aimed at enhancing market confidence in its vaccine development potential.
See More
Valneva and Brazil Launch Pilot Chikungunya Vaccine Program
- Pilot Program Launch: Valneva and Instituto Butantan have initiated a pilot vaccination strategy for the IXCHIQ® vaccine, aiming to evaluate its effectiveness and safety in real-world settings, with plans to vaccinate over 500,000 adults aged 18 to 59.
- Vaccine Coverage Goals: The program targets a vaccine coverage rate of 20% to 40% across ten strategically selected municipalities, addressing public health needs as outlined by the Brazilian Ministry of Health to mitigate chikungunya transmission.
- Global Health Commitment: Valneva's Chief Medical Officer emphasized that this initiative underscores the company's commitment to global preparedness against chikungunya threats, with expectations to generate critical real-world data that reinforces the vaccine's public health value.
- Technology Transfer and Collaboration: Valneva signed a technology transfer agreement with Butantan in 2021, ensuring the vaccine's development and commercialization in Latin America, highlighting the strong collaboration between the two entities in addressing public health challenges.
See More
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.
See More
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.
- Market Decline: U.S. stock futures are broadly lower, with Dow futures falling around 700 points, reflecting investor caution regarding economic outlook, which may impact overall market sentiment and exacerbate volatility in other stocks.
- Other Stock Movements: Shares of Rezolve AI PLC and POET Technologies Inc fell 15% and 11.2% respectively in pre-market trading, indicating widespread investor apprehension towards tech stocks, potentially prompting a reassessment of risk appetite.
- Tesla Update: Tesla's stock fell 2.7% to $425.75 in pre-market trading, despite CEO Elon Musk confirming that vehicles equipped with the AI4 chip will achieve unsupervised autonomous driving, suggesting insufficient market confidence in the electric vehicle sector.
See More
Valneva SE Withdraws IXCHIQ Vaccine Applications Following FDA License Suspension
- 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.
See More
Valneva Withdraws IXCHIQ Vaccine Applications Following FDA Suspension
- Application Withdrawal: Valneva SE has voluntarily withdrawn its biologics license application (BLA) and Investigational New Drug (IND) application for IXCHIQ® in the U.S. following the FDA's suspension in August 2025, highlighting the challenging regulatory landscape.
- Clinical Study Halt: With the FDA placing the IND for IXCHIQ® on clinical hold, Valneva currently has no active clinical studies recruiting participants, which will directly impact the vaccine's market rollout and future revenue expectations.
- Adverse Event Investigation: The hold is linked to a serious adverse event (SAE) reported abroad involving a young adult who received IXCHIQ®, prompting Valneva to actively seek additional information to assess the vaccine's safety, potentially affecting public confidence.
- Market Opportunity Assessment: While IXCHIQ® still has demand among travelers in endemic tropical and subtropical regions, Valneva must engage in further discussions with regulatory authorities to ensure the vaccine's commercial attractiveness aligns with medical needs, influencing its future strategic direction.
See More
Valneva to Showcase Vaccine Progress at J.P. Morgan Conference
- Management Meetings: Valneva SE will engage in one-on-one meetings with existing shareholders during the 44th Annual J.P. Morgan Healthcare Conference from January 12-14, 2026, aiming to strengthen ties with institutional investors and boost market confidence.
- Clinical Progress Discussion: CEO Thomas Lingelbach and CFO Peter Bühler will discuss upcoming pivotal data from the clinical development pipeline, including the Lyme disease vaccine, expected to be released in the first half of this year, which could positively impact future revenues.
- Vaccine Portfolio Showcase: Valneva will highlight its commercial vaccine portfolio, emphasizing its expertise in addressing unmet medical needs, particularly the Lyme disease vaccine candidate partnered with Pfizer, which may open new revenue streams for the company.
- Investor Relations Enhancement: The company encourages institutional investors to schedule meetings through its investor relations department, demonstrating Valneva's commitment to transparency and investor communication, aimed at enhancing market confidence in its vaccine development potential.
See More
