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Investing.com - Jefferies has reduced its price target on Valneva SE (NASDAQ:VALN) to $14.00 from $18.00 while maintaining a Buy rating on the stock. Currently trading at $9.13, Valneva has shown remarkable strength with a 166% gain year-to-date, though InvestingPro data indicates the stock is currently in overbought territory.
The price target cut follows the FDA’s suspension of Valneva’s Ixchiq Biologics License Application (BLA) based on four new serious adverse events reported outside the United States, including three in elderly individuals aged 70-82 years.
According to Jefferies, the FDA cited one death caused by encephalitis attributable to the vaccine and more than 20 serious adverse events related to Chikungunya virus-like illness, including 21 hospitalizations and three deaths in its August 22 press release.
Valneva shares dropped 21% following the FDA announcement, erasing part of the 51% gain the stock had achieved in the previous 30 days amid a developing Chikungunya epidemic.
Jefferies noted that investor focus continues to be on Valneva’s Lyme disease Phase III readout expected by year-end 2025, which the firm believes could move the stock up 50% or down 25%, with a 75% probability of success. InvestingPro analysis shows the company maintains a ’Fair’ overall financial health score, with strong liquidity ratios despite current unprofitability. Get access to 10+ additional ProTips and comprehensive financial analysis with an InvestingPro subscription.
In other recent news, Valneva SE has faced a significant setback as the U.S. Food and Drug Administration (FDA) suspended the license for its chikungunya vaccine, IXCHIQ. This suspension, which requires Valneva to halt shipping and selling the vaccine in the United States, follows reports of four serious adverse events. The FDA’s decision arrives shortly after lifting a recommended pause on the vaccine’s use for individuals aged 60 and older. Meanwhile, H.C. Wainwright has assumed coverage on Valneva with a Buy rating and a price target of $18.00. The firm noted the co-development of VLA15, a Lyme disease vaccine in partnership with Pfizer, which is currently in Phase 3 trials. Pivotal data for VLA15 is expected by the end of 2025, with regulatory submissions anticipated in 2026 and a potential commercial launch in 2027. These developments highlight both challenges and future opportunities for Valneva in the vaccine market.
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