FDA Suspends Marketing of Valneva's Chikungunya Vaccine in U.S. Due to Safety Concerns

The FDA has suspended Valneva's marketing application for its chikungunya vaccine Ixchiq due to safety concerns, including several deaths. The vaccine was initially cleared in 2021, but the FDA has halted its marketing while further investigation is conducted. Valneva is a French biotech company listed on the NASDAQ stock exchange.

The U.S. Food and Drug Administration (FDA) has suspended Valneva's marketing application for its chikungunya vaccine Ixchiq due to serious safety concerns, including several deaths. The vaccine, initially cleared in November 2023 under an accelerated approval pathway, was intended to prevent chikungunya, a mosquito-borne viral disease, in individuals aged 18 and older at increased risk of contracting the virus. The FDA's decision to suspend the marketing application was based on concerns about the vaccine causing chikungunya-like illness in recipients, with one mortality directly linked to Ixchiq and more than 20 serious adverse events similar to chikungunya-like illness reported. The FDA has also recorded 21 hospitalizations and three deaths, with the agency concluding that the vaccine's benefits do not outweigh its risks [1].

Valneva, a French biotech company listed on the NASDAQ stock exchange, has faced challenges with its chikungunya vaccine. In May 2023, the FDA lifted a recommended pause on the use of Ixchiq in individuals aged 60 and older following an investigation into serious adverse events. However, the FDA's recent decision to suspend the marketing application indicates a significant setback for the company. The suspension comes as Valneva was expected to report its Q2 2025 earnings, which may include updates on the company's response to these developments.

Investors should closely monitor the situation as the FDA's decision could have implications for Valneva's stock performance. Analysts have been cautious, with Wall Street analysts forecasting a fall in VALN stock price over the next 12 months. According to Wall Street analysts, the average 1-year price target for VALN is 10.75 USD, with a low forecast of 7.50 USD and a high forecast of 14.00 USD [2]. 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.

References:
[1] https://intellectia.ai/news/stock/valneva-announces-removal-of-fdarecommended-pause-on-use-of-chikungunya-vaccine-ixchiq-in-elderly-and-updates-to-the-prescribing-information
[2] https://seekingalpha.com/news/4488549-valneva-chikungunya-vaccine-suspended-in-us