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On Friday, H.C. Wainwright analysts maintained a Buy rating and a $60.00 price target for Arcturus Therapeutics (NASDAQ:ARCT) shares, significantly above the current trading price of $9.35. According to InvestingPro data, the stock appears undervalued based on its Fair Value analysis, despite facing challenges with a 71% decline over the past year. The firm's optimism follows Arcturus's announcement on April 10 that the FDA has granted Fast Track designation to its influenza vaccine candidate, ARCT-2304.
The Fast Track status was awarded to ARCT-2304, also known as LUNAR-H5N1, due to its potential to protect against the pandemic influenza A H5N1 virus. While the company maintains strong financial flexibility with a current ratio of 4.67 and more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash burn requires monitoring. The vaccine candidate utilizes self-amplifying mRNA (sa-mRNA) technology, which is expected to offer advantages in dosing efficiency and manufacturing speed over traditional vaccine methods.
ARCT-2304 features Arcturus's STARR sa-mRNA technology and its proprietary LUNAR delivery system. This combination is intended to amplify mRNA within the host cells after intramuscular injection, leading to enhanced expression of the haemagglutinin (HA) and neuraminidase (NA) antigens. The vaccine's lyophilized formulation also supports stability under standard refrigeration, which could ease storage and distribution logistics.
Currently, ARCT-2304 is undergoing a randomized, placebo-controlled Phase 1 trial that began in November 2024. The study aims to enroll around 200 healthy adults, with the first inoculation having taken place in December 2024. The primary goal is to evaluate the safety and immune responses at various dosages and vaccination schedules.
H.C. Wainwright analysts pointed out that interim data from the Phase 1 study of ARCT-2304 is expected in the second half of 2025. They also highlighted upcoming milestones for Arcturus, including interim results from a Phase 2 study of ARCT-032 for cystic fibrosis and a Phase 2 study of ARCT-810 for ornithine transcarbamylase deficiency, both anticipated in the second quarter of 2025. With analyst targets ranging from $44 to $140, investors can access detailed financial analysis and 15 additional key insights through InvestingPro's comprehensive research reports, helping navigate this volatile biotech investment.
In other recent news, Arcturus Therapeutics announced that the FDA has granted Fast Track Designation to its mRNA vaccine candidate, ARCT-2304, aimed at the H5N1 influenza virus. This designation is intended to expedite the development and review of drugs that address serious conditions. The company is supported by federal funding for this project and is advancing through Phase 1 clinical trials. Meanwhile, Guggenheim Securities adjusted its outlook on Arcturus, lowering the price target to $45 due to expected limited partner sales of its COVID-19 vaccine, Kostaive, while maintaining a Buy rating. BTIG also made an adjustment, raising its price target slightly to $58 and maintaining a Buy rating, reflecting optimism about Arcturus's pipeline developments. Additionally, H.C. Wainwright reduced its price target for Arcturus to $60, maintaining a Buy rating, citing upcoming interim data from a Phase 2 study for cystic fibrosis treatment. Canaccord Genuity cut its price target to $68, also maintaining a Buy rating, following Arcturus's earnings report and updates on its COVID vaccine and rare disease programs. These developments highlight Arcturus's ongoing efforts in vaccine innovation and potential market impacts.
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