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ARCT のニュース
ARCT のイベント
Arcturus Announces Strategic Collaboration with Thermo Fisher
Arcturus Therapeutics (ARCT) announced a strategic collaboration with Thermo Fisher Scientific (TMO) to help support the Phase 3 development and potential commercialization of ARCT-032, Arcturus' investigational mRNA therapy for Cystic Fibrosis. The collaboration will leverage Thermo Fisher's Accelerator Drug Development solutions, combining manufacturing and clinical research capabilities to support Phase 3 development through potential commercialization. Thermo Fisher will provide integrated manufacturing, clinical research, and commercial readiness services to help accelerate development of ARCT-032 while Arcturus continues to advance the program. Under the agreement, Thermo Fisher will provide Phase 3 manufacturing, clinical research, and related services. If Phase 2 yields positive results, Arcturus expects to conduct its Phase 3 program through Thermo Fisher's PPD(TM) clinical research business. Subject to regulatory approval of ARCT-032, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial agreement.
Arcturus Q1 Revenue $2.1M, Below Consensus
Reports Q1 revenue $2.1M, consensus $6.9M. "Arcturus continues to advance its rare disease therapeutics portfolio. We have initiated enrollment of our 12-week CF Phase 2 study in the first quarter of 2026, earlier than originally anticipated. We remain committed to advancing our inhaled mRNA therapy for people with CF Class I mutations," said Joseph Payne, President & CEO of Arcturus. "Also, during the first quarter of 2026, we met with the FDA regarding the pediatric clinical development strategy for our OTC deficiency program and we now have a clear path toward initiating a pivotal trial which we will align further at the EOP2 meeting later this year. We welcomed two seasoned C-suite leaders, Alan H. Cohen, MD, Chief Medical Officer and Dennis M. Mulroy, Chief Financial Officer to strengthen the executive team."
Arcturus Q4 Revenue $7.2M, Below Consensus
Reports Q4 revenue $7.2M, consensus $14.32M. "Arcturus continues to progress its rare disease therapeutic portfolio. We look forward to aligning with regulators on our clinical development strategy for the ornithine transcarbamylase (OTC) deficiency program, and to initiating our Phase 2, 12-week cystic fibrosis (CF) study in the first half of 2026," said Joseph Payne, President & CEO of Arcturus. "We remain firmly committed to advancing our once-daily inhaled mRNA therapy for people with cystic fibrosis Class I mutations."
Arcturus Therapeutics Files $500M Mixed Securities Shelf
Arcturus Therapeutics files $500M mixed securities shelf
Arcturus Therapeutics announces Q3 earnings per share of 49 cents, below consensus estimate of 80 cents.
Reports Q3 revenue $17.15M, consensus $16.03M. "We were pleased to share the initial findings of ARCT-032 clinical activity with the CF community last month at the NACFC," said Joseph Payne, President & CEO of Arcturus Therapeutics. "Conversations at NACFC with CF patients, physicians, investigators and global experts reinforced our commitment to advance ARCT-032 further into development. We look forward to initiating a 12-week safety and preliminary efficacy study in first half of 2026. Our team is also working diligently to achieve alignment with regulatory agencies regarding pivotal studies of ARCT-810 in adults and young children with OTC deficiency."
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