On September 22, Natera rose 3.1% in regular trading, trading at $382.10/share, with turnover of approximately $57.86 million. The move was driven by the announcement that Japan's Pharmaceuticals and Medical Devices Agency has approved the company's Signatera test as a companion diagnostic for muscle-invasive bladder cancer.

The approval supports using Signatera to guide adjuvant atezolizumab treatment decisions in patients with muscle-invasive bladder cancer. Natera expects to commercially launch the test in Japan in the first half of next year, following approval of atezolizumab for the indication. The regulatory clearance was supported by data from the late-stage IMvigor011 trial. Notably, this marks the second Japanese approval for Signatera, following its earlier clearance for colorectal cancer use in June, reinforcing Natera's expanding international footprint.

The approval builds on strong momentum, including FDA approval of Signatera CDx as a companion diagnostic in bladder cancer in May, an NCCN Category 1 recommendation in June, and EU IVDR certification in July. Multiple analyst firms maintain Buy ratings, with UBS recently raising its price target to $435.

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