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Investing.com - Guggenheim lowered its price target on Valneva SE (NASDAQ:VALN) to $13.00 from $14.00 on Monday, while maintaining a Buy rating on the stock following the company’s first-half 2025 earnings and a regulatory setback for its Ixchiq vaccine. According to InvestingPro data, despite challenges, VALN has delivered impressive YTD returns of nearly 98%, though the company currently trades near its Fair Value.
The price target reduction comes after the FDA suspended the Biologics License Application (BLA) for Valneva’s Ixchiq vaccine in the United States, a development Guggenheim described as surprising given recent indications from other regulatory bodies that safety concerns might be easing.
In response to the suspension, Guggenheim has removed all projected U.S. Ixchiq sales from its financial model and now assumes more limited commercial uptake in Europe due to potential safety concerns and emerging competition.
Despite these adjustments, Guggenheim maintained its Buy rating on Valneva shares ahead of an upcoming Phase 3 data readout for the company’s Lyme disease vaccine, which is being developed in partnership with Pfizer.
The crucial Lyme vaccine data is expected by late fourth quarter 2025 or early first quarter 2026, according to Guggenheim’s analysis.
In other recent news, Valneva SE faced a significant setback as the U.S. Food and Drug Administration (FDA) suspended the license for its chikungunya vaccine, IXCHIQ. This decision was prompted by four new reports of serious adverse events, leading to an immediate halt in shipping and sales of the vaccine in the United States. The suspension comes shortly after the FDA had lifted a previous pause on using the vaccine for individuals aged 60 and older. In light of these developments, Jefferies has reduced its price target for Valneva to $14.00 from $18.00, although it maintained a Buy rating on the stock. Meanwhile, H.C. Wainwright has assumed coverage of Valneva with a Buy rating and set a price target of $18.00. The firm emphasized Valneva’s collaboration with Pfizer on the VLA15 Lyme disease vaccine, which is currently in Phase 3 trials. Key data from this program is expected by the end of 2025, with regulatory submissions planned for 2026 and a potential commercial launch in 2027. These updates reflect the ongoing developments surrounding Valneva and its vaccine initiatives.
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