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Arcturus Therapeutics Holdings Inc. reports developments as a commercial messenger RNA medicines and vaccines company focused on liver and respiratory rare disease therapeutics and infectious disease vaccines. Its news commonly covers pipeline progress for cystic fibrosis and ornithine transcarbamylase deficiency programs, including LUNAR-CF, ARCT-032, LUNAR-OTC and ARCT-810, as well as updates tied to its LUNAR lipid-mediated delivery and STARR self-amplifying mRNA technologies.
Company updates also address KOSTAIVE COVID-19 vaccine activity, partnered vaccine programs with CSL Seqirus, the ARCALIS manufacturing joint venture in Japan, collaboration revenue, research and development spending, quarterly financial results, investor conference participation, and executive or board changes.
Arcturus Therapeutics (ARCT) has initiated Phase 2 dosing for both its Cystic Fibrosis (CF) and Ornithine Transcarbamylase (OTC) deficiency therapeutic programs in December 2024. In the CF study (NCT06747858), participants will receive daily treatments of ARCT-032 over 28 days. For the OTC deficiency program, the first participant received 0.5 mg/kg of ARCT-810 in the United States, with participants scheduled to receive five intravenous infusions over two months.
The company previously completed a placebo-controlled European study for OTC deficiency (N = 8; 0.3 mg/kg) and expanded the Phase 2 clinical program of ARCT-810 into the US with an open-label multiple-dose study (NCT06488313). Interim data for both mRNA therapeutic programs is expected in the first half of 2025.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Joseph Payne, President & CEO, will deliver a presentation at the conference in San Francisco on Wednesday, January 15, 2025, at 9:45 a.m. Pacific Time. Investors and interested parties can access the presentation webcast and replay through the company's investor relations website at ir.arcturusrx.com/investor-calendar.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in three upcoming investor conferences in December 2024. The company will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 3 at 4:30 p.m. ET, attend Citi's 2024 Global Healthcare Conference on December 4, and join another fireside chat at the 7th Annual Evercore HealthCONx Conference on December 5 at 8:45 a.m. ET. Webcast links will be available on the company's website under the Investor Relations/Events section.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in the Jefferies London Healthcare Conference. The presentation is scheduled for Wednesday, November 20, 2024, at 9:30 am GMT in London. Interested parties can access both the live webcast and replay of the presentation through the Investor Relations/Events section on the company's website.
Meiji Seika Pharma announced its investment in ARCALIS, a joint venture between Axcelead and Arcturus Therapeutics focused on mRNA pharmaceuticals and vaccines development. ARCALIS aims to establish comprehensive domestic production of mRNA vaccines in Japan. The collaboration combines ARCALIS' mRNA technology with Meiji's manufacturing expertise to improve vaccine supply in Japan. Meiji plans to supply the domestically produced KOSTAIVE® sa-mRNA vaccine in December 2024, using active ingredients from ARCALIS. This initiative aligns with Japan's strategy to strengthen vaccine development and production systems, ensuring timely delivery of vaccines when needed.
Arcturus Therapeutics (Nasdaq: ARCT) has received FDA clearance to proceed with a clinical trial for ARCT-2304, a self-amplifying mRNA vaccine candidate targeting H5N1 pandemic influenza. The Phase 1 clinical trial, funded by BARDA, will evaluate safety, reactogenicity, and immunogenicity in approximately 200 healthy adults in the United States. The vaccine utilizes Arcturus' STARR® self-amplifying mRNA technology and is part of the company's preparation efforts for potential future pandemics.
Arcturus Therapeutics reported Q3 2024 financial results and pipeline updates. Key highlights include a $25 million commercial milestone from first KOSTAIVE® sales in Japan, and Phase 2 studies for Cystic Fibrosis and OTC Deficiency on track for proof-of-concept data in H1 2025. Revenue was $41.7 million, down from $45.2 million in Q3 2023. Net loss improved to $6.9 million ($0.26 per share) compared to $16.2 million ($0.61 per share) last year. The company maintains a strong cash position of $294.1 million, with runway through Q1 2027.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA vaccines and medicines company, announced it will release its Q3 2024 financial results on November 7, 2024, after market close. The company will also host a conference call and webcast at 4:30 pm ET on the same day to discuss the results and provide a corporate update. The call can be accessed domestically at 1-800-274-8461 and internationally at 1-203-518-9814 using the conference ID: ARCTURUS. A webcast link will be available for streaming.
CSL and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine ARCT-154 maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated:
1. Higher antibody levels against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants.
2. Effectiveness at one-sixth the dose of Comirnaty® (5 μg vs 30 μg).
3. Superior durability of immune response in both younger and older adults.
Additionally, their bivalent vaccine ARCT-2301 showed superior immunogenicity over Comirnaty® bivalent vaccine up to six months post-vaccination. The sa-mRNA platform vaccine targeting the JN.1 variant is now approved in Japan under the name KOSTAIVE®.
CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.
Key findings include:
- ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
- Similar advantages were observed against Omicron BA.4-5 and other variants
- A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®
The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.