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Accuray (ARAY) FDA Events

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FDA Events for Accuray (ARAY)

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

Accuray's Drugs in FDA Review

CyberKnife® - FDA Regulatory Timeline and Events

CyberKnife® is a drug developed by Accuray for the following indication: For Treatment in Men with Localized Prostate 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.

Radixact® System - FDA Regulatory Timeline and Events

Radixact® System is a drug developed by Accuray for the following indication: To Treat Patients with Cancer Using the Accuray Radixact® Radiation Delivery System and VitalHold™ Technology. 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.

Tomo® C Radiation Treatment Delivery System - FDA Regulatory Timeline and Events

Tomo® C Radiation Treatment Delivery System is a drug developed by Accuray for the following indication: precision radiotherapy for cancer patients. 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.

Accuray FDA Events - Frequently Asked Questions

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

In the past two years, Accuray (ARAY) has reported FDA regulatory activity for the following drugs: Radixact® System, CyberKnife® and Tomo® C Radiation Treatment Delivery System.

The most recent FDA-related event for Accuray occurred on May 7, 2025, involving CyberKnife®. The update was categorized as "Data Presentation," with the company reporting: "Accuray Incorporated announced that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife® System in the treatment of prostate cancer at multiple stages of the cancer journey."

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

  • To Treat Patients with Cancer Using the Accuray Radixact® Radiation Delivery System and VitalHold™ Technology - Radixact® System
  • For Treatment in Men with Localized Prostate Cancer - CyberKnife®
  • precision radiotherapy for cancer patients - Tomo® C Radiation Treatment Delivery System

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:ARAY) was last updated on 7/9/2025 by MarketBeat.com Staff
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