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Arcus Biosciences (RCUS) FDA Events

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FDA Events for Arcus Biosciences (RCUS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Arcus Biosciences (RCUS). Over the past two years, Arcus Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ARC-20, casdatifan, quemliclustat, and STAR-221. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Arcus Biosciences' Drugs in FDA Review

ARC-20 - FDA Regulatory Timeline and Events

ARC-20 is a drug developed by Arcus Biosciences for the following indication: In patients that had received both prior TKI and anti-PD-1 therapy. 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.

casdatifan - FDA Regulatory Timeline and Events

casdatifan is a drug developed by Arcus Biosciences for the following indication: In patients with ccRCC. 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.

quemliclustat - FDA Regulatory Timeline and Events

quemliclustat is a drug developed by Arcus Biosciences for the following indication: For Pancreatic Cancer. 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.

STAR-221 - FDA Regulatory Timeline and Events

STAR-221 is a drug developed by Arcus Biosciences for the following indication: for Metastatic Upper GI Cancers. 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.

Arcus Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Arcus Biosciences (RCUS) has reported FDA regulatory activity for the following drugs: ARC-20, casdatifan, quemliclustat and STAR-221.

The most recent FDA-related event for Arcus Biosciences occurred on July 10, 2025, involving quemliclustat. The update was categorized as "Designation Grant," with the company reporting: "Arcus Biosciences, Inc announced that quemliclustat, an investigational small molecule CD73 inhibitor, was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer.."

Current therapies from Arcus Biosciences in review with the FDA target conditions such as:

  • In patients that had received both prior TKI and anti-PD-1 therapy. - ARC-20
  • In patients with ccRCC - casdatifan
  • For Pancreatic Cancer - quemliclustat
  • for Metastatic Upper GI Cancers - STAR-221

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 (NYSE:RCUS) was last updated on 7/10/2025 by MarketBeat.com Staff
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