Natera Submits First PMA Module to the FDA for Signatera™
Natera, Inc. (NTRA)
Last natera, inc. earnings: 2/26 04:10 pm
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Source: Business Wire
Lays groundwork for multiple submissions across cancer types, starting with CDx label in bladder cancer AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the submission of the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, as a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC).This module, submitted on September 28, included the required documentation regarding Natera’s manufacturing and quality control systems, which the Company expects will support all future indications for Signatera as well as other Natera products. The remaining modules for the Signatera MIBC indication, including software, analytical and clinical validation data, are expected to be submitted through 2025 upon completion of the ongoing registrational tria
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NTRA
News
- Natera (NASDAQ:NTRA) had its price target raised by analysts at Canaccord Genuity Group Inc. from $250.00 to $285.00. They now have a "buy" rating on the stock.MarketBeat
- Natera to Participate in the 44th Annual J.P. Morgan Healthcare ConferenceBusiness Wire
- Natera Announces Publication of Signatera™ Analysis from Randomized, Phase III CALGB (Alliance)/SWOG 80702 Study in Colorectal CancerBusiness Wire
- I-SPY 2 Publication in Nature Communications Shows Signatera™ Can Predict Treatment Response and Recurrence Risk in Early-Stage Breast CancerBusiness Wire
- Natera (NASDAQ:NTRA) had its price target raised by analysts at JPMorgan Chase & Co. from $250.00 to $260.00. They now have an "overweight" rating on the stock.MarketBeat
NTRA
Earnings
- 11/6/25 - Miss
NTRA
Sec Filings
- 12/22/25 - Form 4
- 12/19/25 - Form 144
- 12/17/25 - Form 4
- NTRA's page on the SEC website