On Tuesday, Arcturus Therapeutics (NASDAQ: NASDAQ:ARCT) shares maintained Buy rating and $63.00 price target, following the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for Kostaive's approval.
The vaccine, also known as zapomeran, is aimed at preventing COVID-19 infections in adults over 18 in Europe. Currently trading at $16.24, with a market capitalization of $440 million, the stock has seen an 11.5% decline over the past week.
The CHMP's recommendation, announced on December 13, is a significant scientific nod for Kostaive, although it is not a formal regulatory approval. It is, however, a key step toward potential market authorization by the European Commission (EC), which is anticipated to make its decision by early February 2025. According to InvestingPro analysis, the company maintains a GOOD financial health score, suggesting strong positioning for potential market expansion.
Kostaive's approval would mark a major commercial achievement for Arcturus, following the Global Collaboration and Licensing agreement with CSL (OTC:CSLLY) (ASX: CSL) in 2022. The vaccine has already been approved in Japan since November 2023, and a nod from the EMA could further bolster its market presence.
Despite a U.S. COVID-19 vaccine market that is currently dominated by Comirnaty and Spikevax, the firm believes that Kostaive could emerge as a strong competitor, especially with positive head-to-head data. The firm's stance reaffirms the potential of Kostaive in the global vaccine landscape.
Analyst sentiment remains strongly bullish, with a high price target of $140, and InvestingPro's Fair Value analysis suggests the stock is currently undervalued. For deeper insights into Arcturus's market position and growth potential, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
In other recent news, Arcturus Therapeutics has received FDA approval to proceed with a clinical trial for its flu vaccine candidate, ARCT-2304. The upcoming Phase 1 trial, supported by the Biomedical Advanced Research and Development Authority, plans to enroll around 200 healthy adults across the United States.
The company's Q3 2024 earnings report revealed a net loss of $6.9 million, an improvement from the previous year, with revenues totaling $41.7 million.
Arcturus also successfully launched its product, KOSTAIVE, in Japan, bringing in a $25 million milestone payment. Canaccord Genuity maintained a Buy rating on Arcturus shares and increased its price target to $74 from $72. Other recent developments include the expected update on ARCT-032 for cystic fibrosis and ARCT-810 for Ornithine Transcarbamylase deficiency, both scheduled for the first half of 2025.
Finally, the company plans to file a Biologics License Application for KOSTAIVE in the U.S. in H1 2025. These developments showcase the company's continued progress in its various medical programs and its potential for substantial growth in the coming year.
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