EU and US could reach trade deal this weekend - Reuters
On Thursday, H.C. Wainwright reaffirmed a Buy rating on Valneva (EPA:VLS) SE (NASDAQ:VALN) shares, maintaining a $17.00 price target. The stock, which has surged over 54% year-to-date despite a recent 2.87% weekly decline, currently trades well below analysts' consensus target range of $7.10 to $18.00. According to InvestingPro data, the company maintains a Fair Value that suggests potential upside from current levels. The positive stance comes as Valneva and LimmaTech, the private company from which Valneva licensed the Shigella4V2 (S4V2) program, announced the commencement of the first vaccination in the S4V2 Phase 2 study on April 9. The S4V2 vaccine candidate is designed to combat shigellosis, a deadly diarrheal disease caused by Shigella bacteria and has been granted FDA Fast Track designation. With a market capitalization of approximately $503 million and revenue growth of 10.32% in the last twelve months, Valneva demonstrates its commitment to expanding its vaccine portfolio.
The ongoing Phase 2 trial, sponsored and conducted by LimmaTech, aims to assess the safety and immunogenicity of S4V2 in approximately 110 nine-month-old infants. The study's goal is to determine the appropriate dose for Phase 3 trials. Conducted at a single site in Kenya, the trial involves administering a two-dose vaccination at one of two different dose levels of S4V2 or a control vaccine. The study will monitor safety for about six months after the final vaccination, with results expected in the second half of 2025.
Additionally, a Phase 2b Human Challenge Study (CHIM) named S4V03 is in progress. This study is evaluating the safety and preliminary efficacy of the vaccine in roughly 120 healthy Shigella-naïve individuals between the ages of 18 and 50. Valneva has taken on the responsibility for all further research and development, Chemistry, Manufacturing and Controls (CMC), and regulatory activities for the potential global commercialization of S4V2.
While the shigella vaccine candidate is not currently included in Valneva's valuation, H.C. Wainwright views it as an upside call option and has reiterated their Buy rating and $17 price target for the company's stock. Despite operating with moderate debt levels, Valneva maintains strong liquidity with a current ratio of 2.61. For deeper insights into Valneva's financial health, valuation metrics, and additional ProTips, investors can access the comprehensive research report available on InvestingPro, which covers over 1,400 US equities with expert analysis and actionable intelligence.
In other recent news, Valneva SE reported a total revenue of €169.6 million for 2024, a 10% increase from the previous year, although this was below the consensus estimate of €186.0 million. The company's product sales reached €163.3 million, marking a 13% year-over-year growth. Despite these gains, Valneva experienced lower than expected U.S. sales for its Ixchiq vaccine, which was newly launched. H.C. Wainwright adjusted its price target for Valneva to $17, down from $18, while maintaining a Buy rating, citing the initial performance of Ixchiq in the U.S. market.
In contrast, the firm had previously reaffirmed an $18 target following the UK approval of Ixchiq, which is now authorized for use against the chikungunya virus in adults aged 18 and over. The vaccine has shown effectiveness lasting at least three years and has also received approvals in Europe, Canada, and the U.S. Valneva is optimistic about its market potential, anticipating Brazilian approval soon and projecting sales to exceed €100 million in the third year post-launch. Analysts at H.C. Wainwright forecast Ixchiq's sales to grow significantly, reaching €250 million by 2029.
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