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Arcturus Therapeutics Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat ...

Arcturus Therapeutics Holdings Inc. (ARCT) 
Last arcturus therapeutics holdings inc. earnings: 3/11 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.arcturusrx.com/investor-relations
Company Research Source: Business Wire
SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and addressing unmet medical needs within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study May Proceed” notification for the Company’s Investigational New Drug (IND) application, ARCT-032, to treat cystic fibrosis (CF). FDA clearance of the ARCT-032 IND application enables the Company to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with Cystic Fibrosis.“The Phase 2 Study May Proceed notification allows us to investigate ARCT-032 as a potential treatment for CF patients and provides the opportunity to further validate our LUNAR® technology to deliver mRNA via inhalation,” said Dr. Juergen Froehlich, Chief Medical Officer of Arcturus Show less Read more
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