H.C. Wainwright Reiterates Buy Rating on Arcturus Therapeutics (ARCT)

H.C. Wainwright analyst Ed Arce reiterated a Buy rating and $60.00 price target on Arcturus Therapeutics (NASDAQ: ARCT).

The analyst commented: "Arcturus announced on April 10 that the FDA has granted Fast Track designation to ARCT-2304 (LUNAR-H5N1), its self-amplifying mRNA (sa-mRNA) vaccine candidate against influenza A H5N1. This designation is based on ARCT-2304's potential in protecting against the pandemic influenza A H5N1 virus, which remains a major global health concern. ARCT-2304 is a STARR sa-mRNA vaccine formulated with Arcturus' proprietary LUNAR delivery system. It is designed to amplify mRNA within host cells following intramuscular injection, enabling enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens. This approach supports lower dosing compared to traditional mRNA vaccines. Leveraging sa-mRNA technology for pandemic flu vaccine development could support faster manufacturing scale-up and improve response timelines compared to egg- or cell-based methods. As another notable advantage, ARCT-2304's lyophilized formulation is designed to remain stable under standard refrigeration, simplifying storage and minimizing distribution challenges. ARCT-2304 is now in a randomized, placebo-controlled Phase 1 study (NCT06602531) that initiated in November 2024 to enroll approximately 200 healthy adults, with the first inoculation in December 2024. The primary endpoint of this study is to assess the safety and immune responses of ARCT-2304 at three different dose levels and two distinct vaccination schedules, with immune responses evaluated using HA inhibition, virus microneutralization (MN), and NA enzyme-linked lectin assays (ELLA). In addition to interim data from this Phase 1 study expected in 2H25, we point to: (1) interim data from a Phase 2 study of ARCT-032 for the treatment of cystic fibrosis (CF) in 2Q25, and; (2) interim data from an open-label Phase 2 study of ARCT-810 for U.S. patients with ornithine transcarbamylase (OTC) deficiency in 2Q25 as Arcturus's next milestones. Affirm Buy rating and $60 PT."

For an analyst ratings summary and ratings history on Arcturus Therapeutics click here. For more ratings news on Arcturus Therapeutics click here.

Shares of Arcturus Therapeutics closed at $9.35 yesterday.

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