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On Tuesday, Arcturus Therapeutics (NASDAQ:ARCT) received continued support from H.C. Wainwright, with analyst Ed Arce affirming a Buy rating and maintaining a $63.00 price target for the company’s stock. According to InvestingPro data, analyst targets range from $41 to $140, suggesting significant upside potential from the current price of $18.05. The stock has shown strong momentum with a 12.3% gain over the past week. The endorsement follows the European Commission’s (EC) recent approval of Arcturus’s self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, Kostaive, for individuals 18 years and older.
The EC’s marketing authorization, announced on February 14, 2025, is applicable across all European Union member states and European Economic Area countries, marking the first sa-mRNA COVID-19 vaccine to receive approval from the EC. Arcturus’s partner, CSL (OTC:CSLLY) Seqirus, which holds the global rights to Kostaive, is actively working to optimize the vaccine’s formulation for availability in Europe as promptly as possible. InvestingPro analysis shows the company maintains a strong financial position with a current ratio of 4.76, indicating ample liquidity to support its commercialization efforts.
The positive stance from H.C. Wainwright was anticipated, considering the favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on December 12, 2024. Kostaive’s approval is underpinned by robust clinical data from multiple studies, including an integrated Phase 1/2/3 trial that confirmed the vaccine’s efficacy and tolerability.
Moreover, Phase 3 booster trials of Kostaive demonstrated superior immunogenicity compared to a conventional mRNA COVID-19 vaccine. Follow-up analysis of Kostaive as a booster dose also revealed its potential to induce stronger and longer-lasting antibody responses against various SARS-CoV-2 strains, sustaining effectiveness for up to a year post-vaccination in both younger and older adults.
Looking ahead, the next significant development for Kostaive is expected to be a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2025, which would pave the way for the vaccine’s introduction to the U.S. market. With a beta of 2.62, investors should note the stock’s higher volatility compared to the market. InvestingPro subscribers have access to 8 additional ProTips and comprehensive financial analysis to better evaluate the company’s potential ahead of this crucial regulatory milestone.
In other recent news, Arcturus Therapeutics has been making significant strides in its operations. BTIG analysts have maintained a Buy rating on Arcturus Therapeutics shares and increased the price target from $41.00 to $48.00, following a favorable opinion from the Committee for Medicinal Products for Human Use regarding Arcturus’s SAM-RNA technology used in their KOSTAIVE vaccine. The analysts believe this endorsement could foreshadow a similar outcome in the United States.
In a major development, Arcturus Therapeutics appointed Dr. Moncef Slaoui as its Chair Designate. Dr. Slaoui, a notable figure in the pharmaceutical industry, has been a member of Arcturus’s Board of Directors since June 2024. His appointment is expected to bring significant contributions to Arcturus’s therapeutic and vaccine development programs.
Furthermore, H.C. Wainwright reiterated a Buy rating and a price target of $63 on Arcturus Therapeutics shares. This endorsement came after the announcement that Meiji Seika Pharma has been granted approval for a key amendment related to the COVID-19 vaccine Kostaive, allowing for the integration of domestic production facilities into the vaccine’s supply chain in Japan.
Arcturus Therapeutics has also initiated dosing in two mid-stage clinical studies, placing the company on a trajectory to publish interim results within the first half of this year. This development has been positively received by investors and is expected to shape the company’s future and its position within the biotech industry.
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