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
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US:NASDAQ Investor Relations:
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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
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ARCT
News
- Vicebio Advances Clinical Study of RSV/hMPV Bivalent Vaccine & Strengthens Board with Appointments of World Class Veterans [Yahoo! Finance]Yahoo! Finance
- Arcturus Therapeutics to Present at Jefferies London Healthcare ConferenceBusiness Wire
- Meiji Seika Pharma Announces Investment in ARCALIS, Inc.Business Wire
- Arcturus gets FDA clearance for H5N1 avian flu vaccine study [Seeking Alpha]Seeking Alpha
- Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical TrialBusiness Wire
ARCT
Earnings
- 11/7/24 - Beat
ARCT
Sec Filings
- 11/8/24 - Form SC
- 11/7/24 - Form 10-Q
- 11/7/24 - Form 8-K
- ARCT's page on the SEC website