Arcturus stock holds $63 target amid Japan production nod

On Monday, H.C. Wainwright maintained a positive stance on Arcturus Therapeutics (NASDAQ:ARCT) shares, reiterating a Buy rating and a price target of $63. Currently trading at $16.97, the stock has significant upside potential according to InvestingPro data, with analyst targets ranging from $41 to $140. The firm’s endorsement follows the announcement that Meiji Seika Pharma, a division of Meiji Holdings trading on the Tokyo Stock Exchange under ticker 2269, has been granted approval for a key amendment related to the COVID-19 vaccine Kostaive. On January 31, Meiji Seika Pharma confirmed the authorization to include domestic production sites in Japan for the vaccine’s manufacturing and marketing.

The vaccine, Kostaive, which is distributed by Meiji Seika Pharma in Japan, is a self-amplifying mRNA vaccine developed in partnership with Arcturus’ collaborator CSL (OTC:CSLLY) Seqirus, a subsidiary of CSL Limited. The amendment allows for the integration of domestic production facilities into the vaccine’s supply chain, a significant step for local pharmaceutical manufacturing. InvestingPro analysis shows Arcturus maintains a strong financial position with a current ratio of 4.76, indicating robust liquidity to support its manufacturing initiatives.

The production of Kostaive in Japan is a collaborative effort between ARCALIS, a joint venture established by Arcturus and Axcelead, Inc., and Meiji Seika Pharmatech, a subsidiary of Meiji Seika Pharma. The ARCALIS facilities located in Minami-soma City, Fukushima Prefecture, alongside Meiji Seika Pharmatech, have now been officially designated as manufacturing sites for Kostaive, with CSL Seqirus managing the technology transfer process. This approval marks a milestone as domestically produced Kostaive is now authorized for commercial distribution in Japan.

Looking ahead, Arcturus anticipates further developments for Kostaive. The European Commission is expected to approve the vaccine for the prevention of COVID-19 infections in adults aged 18 and over around early February 2025, following a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use in December 2024. Additionally, Arcturus plans to file a Biologics License Application (BLA) with the FDA in the first half of 2025, aiming to introduce Kostaive to the U.S. market.

H.C. Wainwright’s reiterated Buy rating and price target reflect confidence in Arcturus’ ongoing initiatives and the potential market opportunities for Kostaive in the global vaccine landscape. While the company’s revenue declined 45.85% in the last twelve months, InvestingPro indicates the stock is currently undervalued based on its Fair Value analysis. Investors seeking deeper insights can access the comprehensive Pro Research Report, which provides detailed analysis of Arcturus and over 1,400 other US stocks, along with 7 additional exclusive ProTips about the company’s financial health and market position.

In other recent news, Arcturus Therapeutics has been making significant strides in its operations. The company has initiated dosing in Phase 2 multiple ascending dose studies for Cystic Fibrosis and Ornithine Transcarbamylase deficiency, with interim results expected in the first half of this year. Analysts from BTIG, H.C. Wainwright, and Canaccord Genuity have assigned a Buy rating to Arcturus, with price targets ranging from $41 to $74, highlighting the company’s robust financial health.

Arcturus also reported a net loss of $6.9 million for Q3 2024, an improvement from the previous year, with revenues totaling $41.7 million. The company’s COVID-19 vaccine, Kostaive, has received a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, a crucial step towards potential market authorization by the European Commission.

The company has received a "Study Can Proceed" notification from the FDA for its flu vaccine candidate, ARCT-2304, and plans to file a Biologics License Application for Kostaive in the U.S. in H1 2025. These recent developments indicate the company’s continuous progress in its various medical programs and its potential for significant growth in the coming year.

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