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Natera (NTRA) FDA Events

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FDA Events for Natera (NTRA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Natera (NTRA). Over the past two years, Natera has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IMvigor011, Latitude™, Signatera, and SWOG. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Natera's Drugs in FDA Review

IMvigor011 - FDA Regulatory Timeline and Events

IMvigor011 is a drug developed by Natera for the following indication: in Muscle-Invasive Bladder 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.

Latitude™ - FDA Regulatory Timeline and Events

Latitude™ is a drug developed by Natera for the following indication: For Colorectal 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.

Signatera - FDA Regulatory Timeline and Events

Signatera is a drug developed by Natera for the following indication: MRD Test for cancer therapies. 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.

SWOG 80702 - FDA Regulatory Timeline and Events

SWOG 80702 is a drug developed by Natera for the following indication: In Colorectal 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.

Natera FDA Events - Frequently Asked Questions

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

In the past two years, Natera (NTRA) has reported FDA regulatory activity for the following drugs: Signatera, Latitude™, SWOG 80702 and IMvigor011.

The most recent FDA-related event for Natera occurred on July 7, 2025, involving Latitude™. The update was categorized as "Data," with the company reporting: "Natera, Inc announced data from a colorectal cancer (CRC) study of its tissue-free Latitude™ MRD assay, which were presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI)."

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

  • MRD Test for cancer therapies - Signatera
  • For Colorectal Cancer - Latitude™
  • In Colorectal Cancer - SWOG 80702
  • in Muscle-Invasive Bladder Cancer - IMvigor011

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