Free Trial

Natera (NTRA) FDA Approvals

Natera logo
$140.96 +5.12 (+3.77%)
Closing price 04:00 PM Eastern
Extended Trading
$142.25 +1.29 (+0.92%)
As of 05:14 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.

Natera's Drugs in the FDA Approval Process

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™, Prospera, Signatera, and SWOG. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

IMvigor011 FDA Regulatory 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 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.

Prospera FDA Regulatory Events

Prospera is a drug developed by Natera for the following indication: CfDNA testing. 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 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

In the past two years, Natera (NTRA) has not received FDA approval for any therapies. However, the company does have 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, Prospera, Latitude™, SWOG 80702 and IMvigor011.

The most recent FDA-related event for Natera occurred on July 24, 2025, involving Prospera. The update was categorized as "Findings Update," with the company reporting: "Natera, Inc. announced that the American Journal of Transplantation published findings from the PEDAL study. PEDAL is the first prospective multi-center trial evaluating longitudinal trends of donor-derived cell-free DNA (dd-cfDNA) to determine the prognostic ability of Prospera in assessing outcomes following kidney transplant rejection."

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

  • MRD Test for cancer therapies - Signatera
  • CfDNA testing - Prospera
  • 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 7/30/2025 by MarketBeat.com Staff
From Our Partners