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Coherus Oncology (CHRS) FDA Events

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FDA Events for Coherus Oncology (CHRS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Coherus Oncology (CHRS). Over the past two years, Coherus Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as casdozo and CHS-114. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Coherus Oncology's Drugs in FDA Review

casdozo - FDA Regulatory Timeline and Events

casdozo is a drug developed by Coherus Oncology for the following indication: Designed to inhibit the activity of this immunosuppressive cytokine. 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.

CHS-114 - FDA Regulatory Timeline and Events

CHS-114 is a drug developed by Coherus Oncology for the following indication: In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). 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.

Coherus Oncology FDA Events - Frequently Asked Questions

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

In the past two years, Coherus Oncology (CHRS) has reported FDA regulatory activity for the following drugs: CHS-114 and casdozo.

The most recent FDA-related event for Coherus Oncology occurred on April 28, 2025, involving CHS-114. The update was categorized as "Data," with the company reporting: "Coherus BioSciences, Inc announced data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) evaluating two pharmacologically active doses of CHS-114 for dose optimization."

Current therapies from Coherus Oncology in review with the FDA target conditions such as:

  • In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) - CHS-114
  • Designed to inhibit the activity of this immunosuppressive cytokine - casdozo

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