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Oncolytics Biotech (ONCY) FDA Events

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FDA Events for Oncolytics Biotech (ONCY)

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

Oncolytics Biotech's Drugs in FDA Review

atezolizumab (Tecentriq) - FDA Regulatory Timeline and Events

atezolizumab (Tecentriq) is a drug developed by Oncolytics Biotech for the following indication: Early-stage breast 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.

Pelareorep - FDA Regulatory Timeline and Events

Pelareorep is a drug developed by Oncolytics Biotech for the following indication: In Breast 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.

Oncolytics Biotech FDA Events - Frequently Asked Questions

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

In the past two years, Oncolytics Biotech (ONCY) has reported FDA regulatory activity for the following drugs: Pelareorep and atezolizumab (Tecentriq).

The most recent FDA-related event for Oncolytics Biotech occurred on July 8, 2025, involving Pelareorep. The update was categorized as "Clinical Data," with the company reporting: "Oncolytics Biotech® Inc announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company's intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies."

Current therapies from Oncolytics Biotech in review with the FDA target conditions such as:

  • In Breast Cancer - Pelareorep
  • Early-stage breast cancer - atezolizumab (Tecentriq)

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