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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.
CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October COVID-19 vaccination campaign.
KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine. Clinical evidence supports its safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.
CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October 2024 vaccination campaign.
KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine for adults. Clinical data showed superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.
Arcturus Therapeutics (Nasdaq: ARCT) has received FDA clearance for its Investigational New Drug (IND) application for ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF). This clearance allows Arcturus to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCT-032 in CF patients. The study will focus on individuals who do not qualify for or benefit from CFTR modulator therapy.
Dr. Juergen Froehlich, Chief Medical Officer of Arcturus, stated that this development provides an opportunity to further validate their LUNAR® technology for delivering mRNA via inhalation. The study will assess ARCT-032 administered over several weeks at multiple dose levels in CF patients.
Arcturus Therapeutics Holdings Inc. (ARCT), a global mRNA medicines company, has announced its participation in several upcoming investor and scientific conferences in September 2024. These include:
- Wells Fargo 2024 Healthcare Conference (Fireside Chat) on September 4
- RNA Leaders USA Conference (Presentation) on September 5
- H.C. Wainwright 26th Annual Global Investment Conference (Presentation) on September 9
- Cantor Fitzgerald Annual Healthcare Conference (Fireside Chat) on September 18
Arcturus focuses on developing infectious disease vaccines and addressing unmet medical needs in liver and respiratory rare diseases. Investors can access webcast links for these events through the Investor Relations/Events section of the company's website.
Arcturus Therapeutics (ARCT) announced its Q2 2024 financial results and pipeline progress. Key highlights include:
1. IND submitted for Phase 2 trial of ARCT-032 for cystic fibrosis
2. ARCT-810 (OTC deficiency) Phase 2 interim data expected in Q4
3. Kostaive® on track for Q4 commercial launch in Japan
4. Q2 revenue of $49.9 million, up from $10.5 million in Q2 2023
5. Net loss of $17.2 million ($0.64 per share) compared to $52.6 million ($1.98 per share) in Q2 2023
6. Cash position of $317.2 million as of June 30, 2024
The company's pipeline progress and financial results demonstrate continued advancement in mRNA therapeutics and a strengthened financial position.
Arcturus Therapeutics Holdings (Nasdaq: ARCT), a global mRNA medicines company, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event is scheduled for Tuesday, August 13, 2024, at 9:30 am Eastern Time in Boston. Arcturus specializes in developing infectious disease vaccines and treatments for liver and respiratory rare diseases.
Investors and interested parties can access a webcast and replay of Arcturus' presentation through the company's website. The presentation will be available in the 'Investor Relations/Events' section at https://ir.arcturusrx.com/investor-calendar. This conference appearance provides an opportunity for Arcturus to showcase its progress and potential to a wider audience of growth-oriented investors.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a global mRNA medicines company, has announced it will release its financial results for the second quarter of 2024 after the market close on Monday, August 5, 2024. The company will also host a conference call and webcast at 4:30 pm Eastern Time on the same day to discuss the results.
Arcturus focuses on developing infectious disease vaccines and medicines for liver and respiratory rare diseases. Investors and interested parties can join the earnings call using the provided domestic and international phone numbers or access the webcast through the company's website.
Arcturus Therapeutics (ARCT), a company specializing in mRNA medicines, provided updates on its ARCT-810 and ARCT-032 programs. The ARCT-810 Phase 2 study for OTC deficiency completed enrollment in Europe, with data expected later this year. This program is expanding in the U.S. to include more severely affected patients. ARCT-032, aimed at treating cystic fibrosis (CF), will submit an IND for a Phase 2 multiple ascending dose study within 60 days, based on positive safety data from previous trials. Key updates include the completion of subject enrollment in Europe for ARCT-810, the expansion of this program in the U.S., and promising preliminary results for ARCT-032 in treating CF patients.
Arcturus Therapeutics (Nasdaq: ARCT) has announced the appointment of Dr. Moncef Slaoui to its Board of Directors. Dr. Slaoui, known for his role as Chief Scientific Advisor for Operation Warp Speed, brings extensive experience in pharmaceutical innovation, development, and commercialization. He has held numerous leadership positions, including at GlaxoSmithKline, where he was instrumental in the development of 14 new vaccines. Dr. Slaoui aims to advance Arcturus' pipeline of mRNA vaccines and therapeutics using next-generation technologies.
Arcturus Therapeutics announced promising results from their Phase 1 and Phase 1b interim trials of ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF). The trials, presented at the 47th European Cystic Fibrosis Conference, demonstrated that ARCT-032 is safe and well-tolerated with no serious adverse events reported. Among the 36 study participants, 4 adults with CF showed a +4.0% average absolute improvement in lung function (FEV1) and a +5.8% relative change on Day 8 after two doses. The data aligns with pre-clinical CF ferret model results. Participants with different CF mutations and those on Trikafta® showed favorable responses. Mild-to-moderate febrile reactions were noted in some healthy volunteers but were managed with albuterol. No serious adverse events or dose-limiting toxicities were observed.