Natera Stock Hits 52-Week High on Japanese Approval for Cancer Test

Shares of Natera (NASDAQ:NTRA) climbed to a new 52-week high on Tuesday after the molecular diagnostics company announced it had received regulatory approval in Japan for its Signatera cancer test. The approval expands the test's use in a key international market, fueling a stock run that has seen its value increase by approximately 22% since the beginning of September.

Regulatory Milestone in Japan

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved Natera’s Signatera minimal residual disease (MRD) test as a companion diagnostic. The approval specifically covers its use to guide adjuvant treatment decisions with atezolizumab (Roche’s Tecentriq) for patients with muscle-invasive bladder cancer. The decision was supported by data from the Phase 3 IMvigor011 clinical trial.

This marks the second PMDA approval for Signatera in Japan, following a nod for colorectal cancer in June. Natera is targeting a commercial launch for the new bladder cancer indication in the first half of 2027. "We look forward to launching this second Signatera MRD indication in Japan," said Alexey Aleshin, Natera’s chief medical officer and general manager of oncology, in a statement.

Market Reaction

Ad

The news sent Natera's shares to a fresh 52-week high, trading in a range of $387-$390 on Tuesday before closing at $387.44, according to StockStory. The gain builds on recent momentum, with the stock climbing from an entry level of $320.76 at the start of the month. As of Monday's close, the company's market capitalization exceeded $53 billion, according to data from WallStreetZen.

Building on Business Momentum

The regulatory win follows a positive business update from Natera at a mid-September healthcare conference. The company disclosed several key performance indicators, highlighting strong growth for its Signatera test:

• Record sequential unit additions of approximately 34,000.
• Average selling price increased to roughly $1,275.
• Quarterly revenue grew 37.7% year-over-year to $752.8 million.
• The company guided for full-year revenue around a $2.9 billion midpoint.