Welcome to our dedicated page for Arcturus Therape news (Ticker: ARCT), a resource for investors and traders seeking the latest updates and insights on Arcturus Therape stock.
Arcturus Therapeutics generates news primarily around clinical trial results, regulatory interactions with the FDA, and partnerships with pharmaceutical companies for rare disease drug development. The company's news flow reflects the milestone-driven nature of biotechnology development, where Phase 1, 2, and 3 trial results determine whether mRNA therapeutics advance toward approval or require program adjustments.
Investors follow Arcturus news to track which rare disease programs receive FDA designations like Fast Track or Orphan Drug status, signals that regulatory pathways may accelerate. Partnership announcements reveal how the company funds development through collaborations, with upfront payments and milestone structures that impact financial runway. Clinical data presentations at medical conferences often precede formal press releases, making comprehensive news coverage essential for staying current on pipeline progress.
Quarterly earnings reports provide updates on cash positions, research spending, and management guidance on upcoming clinical milestones. For clinical-stage biotechnology companies, these financial updates matter less for revenue figures than for burn rate analysis and timing of potential financing events. News about manufacturing capabilities, regulatory submissions, and intellectual property developments shapes expectations for commercialization timelines.
The biotechnology sector moves on binary events where single trial results can validate or eliminate years of research investment. Following Arcturus news helps investors understand which programs progress, how partnerships evolve, and when the company might need additional capital. Track earnings calls, FDA correspondence, clinical trial updates, and partnership developments as they happen.
Arcturus Therapeutics Holdings (NASDAQ: ARCT) announced a public offering of 3,264,151 shares at $53.00 each, aiming to raise approximately $173 million. The gross proceeds will support the development of its LUNAR-COV19 vaccine and other clinical programs. Additionally, an option for underwriters to purchase 489,622 more shares is available. The closing of the offering is expected by July 31, 2020. This follows an effective shelf registration statement filed with the SEC earlier this year.
Arcturus Therapeutics Holdings (Nasdaq: ARCT) has secured a binding term sheet with Israel's Ministry of Health to supply its COVID-19 vaccine candidate, LUNAR-COV19. This makes Israel the second country to reserve this vaccine. The final supply agreement is expected within 30 days, contingent on achieving clinical and regulatory milestones. Arcturus aims to produce hundreds of millions of doses in 2020 and 2021, following successful clinical developments and partnerships, including a recent trial approval in Singapore.
Arcturus Therapeutics Holdings (Nasdaq: ARCT) has received approval from the Singapore Health Sciences Authority to proceed with the Clinical Trial Application for its COVID-19 vaccine candidate, LUNAR-COV19. This vaccine employs the innovative STARR™ mRNA technology, which may elicit strong immune responses at low doses. Initial preclinical data indicates that a single dose can boost antibody levels for 50 days. The upcoming human trial will assess safety and immune response in up to 108 adults, including older adults, marking a significant step in Arcturus’ efforts to develop effective COVID-19 vaccines.
Arcturus Therapeutics (Nasdaq: ARCT) announced the formation of a Vaccine Platform Scientific Advisory Board (SAB) with top experts in virology and vaccine development for its LUNAR-COV19 COVID-19 vaccine program. The SAB's insights aim to enhance the vaccine's development pathway. The company is on track for clinical trials scheduled for summer 2020. Arcturus utilizes innovative self-replicating mRNA technology, potentially requiring only a single low-dose administration for effective immunity. The SAB includes notable figures like former Kansas Governor Jeff Colyer and Duke-NUS professor Ooi Eng Eong.
On June 11, 2020, Arcturus Therapeutics Holdings announced that CEO Joseph Payne will present at the Raymond James Human Health Innovation Conference, scheduled for June 15-18, 2020. The presentation is set for 3:00 pm Eastern Time on June 18. Arcturus, based in San Diego, focuses on developing messenger RNA therapeutics for rare diseases and vaccines. The company's innovative technologies include LUNAR® lipid-mediated delivery and STARR™ mRNA Technology. Arcturus has a diverse pipeline targeting conditions like Ornithine Transcarbamylase Deficiency and SARS-CoV-2.
Arcturus Therapeutics has commenced a Phase 1 study for ARCT-810, an mRNA-based therapeutic targeting Ornithine Transcarbamylase (OTC) deficiency. The first healthy volunteer has been dosed in this double-blind, placebo-controlled trial, assessing safety, tolerability, and pharmacokinetics. OTC deficiency, a serious urea cycle disorder affecting approximately 10,000 globally, currently lacks FDA-approved treatments. The ARCT-810 program, leveraging Arcturus’ LUNAR delivery platform, aims to express the OTC enzyme in liver cells, potentially preventing severe neurological damage.
Arcturus Therapeutics (Nasdaq: ARCT) announced promising preclinical data for its COVID-19 vaccine candidate, LUNAR-COV19, demonstrating robust adaptive immune responses. Key findings include a significant increase in CD8+ T-cells and a balanced Th1/Th2 response. The STARR™ mRNA technology elicited higher anti-spike protein antibodies compared to conventional mRNA across all doses, particularly at lower doses. With plans for human clinical trials set for summer 2020, the results indicate strong support for the vaccine's effectiveness and potential for clinical protection against COVID-19.
Arcturus Therapeutics Holdings Inc. announced significant progress in its COVID-19 STARR™ mRNA vaccine, LUNAR-COV19, showcasing robust preclinical immunogenicity with a single low dose. The company successfully raised $75.5 million through a secondary stock offering and maintains $59.5 million in cash, sufficient to sustain operations for over two years. The net loss for Q1 2020 was approximately $9.8 million, with revenues declining to $2.6 million compared to $4.3 million in Q1 2019. Clinical trials for the vaccine are set to begin this summer, with manufacturing support from Catalent.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) will announce its financial results for Q1 2020 after market close on May 7, 2020. A conference call and webcast to discuss the results will be held at 4:30 PM ET on the same day. The company focuses on developing mRNA therapeutics for rare diseases and vaccines, with a robust pipeline that includes candidates for conditions such as Ornithine Transcarbamylase Deficiency, Cystic Fibrosis, and a self-replicating mRNA vaccine for SARS-CoV-2.
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