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Cue Biopharma (CUE) FDA Events

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FDA Events for Cue Biopharma (CUE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cue Biopharma (CUE). Over the past two years, Cue Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CUE-101 and CUE-401. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cue Biopharma's Drugs in FDA Review

CUE-101 - FDA Regulatory Timeline and Events

CUE-101 is a drug developed by Cue Biopharma for the following indication: HPV+ recurrent/metastatic head and neck 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.

CUE-401 - FDA Regulatory Timeline and Events

CUE-401 is a drug developed by Cue Biopharma for the following indication: In the Treatment of Autoimmune Disease. 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.

Cue Biopharma FDA Events - Frequently Asked Questions

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

In the past two years, Cue Biopharma (CUE) has reported FDA regulatory activity for the following drugs: CUE-101 and CUE-401.

The most recent FDA-related event for Cue Biopharma occurred on July 1, 2025, involving CUE-101. The update was categorized as "Provided Update," with the company reporting: "Cue Biopharma, provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series."

Current therapies from Cue Biopharma in review with the FDA target conditions such as:

  • HPV+ recurrent/metastatic head and neck cancer - CUE-101
  • In the Treatment of Autoimmune Disease - CUE-401

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:CUE) was last updated on 7/10/2025 by MarketBeat.com Staff
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