Valneva Withdraws IXCHIQ Vaccine Applications Following FDA Suspension
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 19 2026
0mins
Source: Globenewswire
- Application Withdrawal: Valneva SE has voluntarily withdrawn its biologics license application (BLA) and Investigational New Drug (IND) application for IXCHIQ® in the U.S. following the FDA's suspension in August 2025,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.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy VALN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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.
Continue Reading
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.
Continue Reading