Press release
Arcturus Therapeutics Announces Second Quarter 2023 Financial Update and Pipeline Progress
ARCT-154 Phase 3 COVID-19 booster trial achieved primary endpoint demonstrating strong immune response and favorable safety profile Meiji Seika Pharma
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nARCT-154 Phase 3 COVID-19 booster trial achieved primary endpoint demonstrating strong immune response and favorable safety profile\n\n\nMeiji Seika Pharma submitted ARCT-154 New Drug Application in Japan\n\n\nNew ARCT-154 booster clinical data demonstrate one-year durability across a panel of variants\n\n\nReceived FDA Fast Track Designation and Rare Pediatric Disease Designation for ARCT-810 for OTC deficiency\n\n\nReceived regulatory approval of ARCT-032 to proceed into a Phase 1b clinical study in CF patients\n\n\nInvestor conference call at 4:30 p.m. ET today\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus Therapeutics Holdings Inc. (the “Company,” “Arcturus,” Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced its financial results for the second quarter and six months ended June 30, 2023 and provided corporate updates.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230807532754/en/Geometric mean fold rise (GMFR) of neutralizing antibodies against SARS-CoV-2 variants (versus pre-booster levels) after ARCT-154 booster vaccination measured by validated pseudoviral microneutralization assays (N=12). Error bars represent the 95% CI. GMFR values are included in white. Participants who received any COVID-19 vaccines or had laboratory-confirmed SARS-CoV-2 infection during the follow-up period were excluded from immunogenicity analysis at sampling times after the event. (Graphic: Arcturus Therapeutics)\n“Arcturus has continued to achieve significant operational progress alongside our exclusive global vaccines partner CSL Seqirus, highlighted by the NDA submission of ARCT-154, for the COVID-19 primary series vaccine and booster, in Japan by CSL Seqirus’ partner Meiji Seika Pharma,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “As demonstrated by the recently published ARCT-154 Phase 3 head-to-head booster data versus Comirnaty®, we believe that our next generation STARR® mRNA platform is meaningfully differentiated. In addition to ARCT-154, we have also made significant progress with other clinical and pre-clinical mRNA therapeutic programs, and we look forward to sharing clinical data from our A...