Arcturus Therapeutics Holdings, Inc. (NASDAQ: ARCT) is a San Diego-based, clinical-stage mRNA medicine and vaccine company, which is focusing on treatments around respiratory and liver diseases. The biotech company develops its treatment candidates utilizing its unique technologies: LUNAR lipid-mediated delivery, STARR mRNA technology, and mRNA drug substance and product manufacturing.
Shares of the biotech company are rallying 34% through early trading on Tuesday, August 3, 2021. Over the past three months, Arcturus Therapeutics has seen average daily volume of 506,020 shares. However, volume of 2.71 million shares or dollar volume of $126.31 million, has already exchanged hands through early trading Tuesday.
Shares of Arcturus Therapeutics are gaining after the company announced that its Clinical Trial Application (CTA) has been approved by the Singapore Health Sciences Authority (HSA). The clinical trial will focus on two of the company’s STARR mRNA vaccine candidates, ARCT-154 and ARCT-165, which are next-generation candidates to treat COVID variants of concern. The Phase 1 / 2 clinical trial will test both candidates as a primary vaccine and as a booster.
During pre-clinical studies, Arcturus Therapeutics notes that both vaccine candidates have demonstrated “strong neutralizing immunogenicity” in non-human primates to the Alpha, Beta, Gamma, and Delta COVID variants. Clinical testing in Singapore and Vietnam (recently announced) will provide further insight into the vaccine candidates’ COVID-neutralizing properties.
“SARS-CoV-2 variants are an increasing public health concern, and we believe that ARCT-154 and ARCT-165 may be well designed to elicit potent immunogenicity to a broad range of emerging variants, including the highly contagious Delta variant. We are pleased to have obtained approval from the Singapore Health Sciences Authority to proceed with the Phase 1/2 clinical trial of ARCT-154 and ARCT-165, and we look forward to the initiation of the trial in Singapore in the coming weeks,” said Joseph Payne, President and CEO of Arcturus.
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