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Arcturus Therapeutics (ARCT) FDA Events

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FDA Events for Arcturus Therapeutics (ARCT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Arcturus Therapeutics (ARCT). Over the past two years, Arcturus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ARCT-032, ARCT-154, ARCT-2304, ARCT-810, and LUNAR-H5N1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Arcturus Therapeutics' Drugs in FDA Review

ARCT-032 - FDA Regulatory Timeline and Events

ARCT-032 is a drug developed by Arcturus Therapeutics for the following indication: For The Treatment Of Cystic Fibrosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ARCT-154 - FDA Regulatory Timeline and Events

ARCT-154 is a drug developed by Arcturus Therapeutics for the following indication: SARS-CoV-2 Delta Variant and Other Variants of Concern. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ARCT-2304 - FDA Regulatory Timeline and Events

ARCT-2304 is a drug developed by Arcturus Therapeutics for the following indication: For pandemic influenza disease caused by H5N1 virus. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ARCT-810 - FDA Regulatory Timeline and Events

ARCT-810 is a drug developed by Arcturus Therapeutics for the following indication: To treat ornithine transcarbamylase deficiency. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LUNAR-H5N1 - FDA Regulatory Timeline and Events

LUNAR-H5N1 is a drug developed by Arcturus Therapeutics for the following indication: For H5N1 Flu Vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Arcturus Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Arcturus Therapeutics (ARCT) has reported FDA regulatory activity for the following drugs: ARCT-032, ARCT-810, ARCT-2304, ARCT-154 and LUNAR-H5N1.

The most recent FDA-related event for Arcturus Therapeutics occurred on June 23, 2025, involving ARCT-810. The update was categorized as "Presentation," with the company reporting: "Arcturus Therapeutics Holdings Inc announced that it will host a virtual KOL presentation of ARCT-810 Phase 2 interim data for Ornithine Transcarbamylase (OTC) deficiencyon Monday, June 30, 2025, at 12:00 p.m. ET."

Current therapies from Arcturus Therapeutics in review with the FDA target conditions such as:

  • For The Treatment Of Cystic Fibrosis - ARCT-032
  • To treat ornithine transcarbamylase deficiency - ARCT-810
  • For pandemic influenza disease caused by H5N1 virus. - ARCT-2304
  • SARS-CoV-2 Delta Variant and Other Variants of Concern - ARCT-154
  • For H5N1 Flu Vaccine - LUNAR-H5N1

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ARCT) was last updated on 7/10/2025 by MarketBeat.com Staff
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