We flagged it early: This diagnostics stock is up +22% after a regulatory win
Natera's shares surged 22% following a significant regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA approved Natera's Signatera test as a companion diagnostic to assist in decision-making for adjuvant atezolizumab (Roche's Tecentriq) treatment in muscle-invasive bladder cancer. This approval is the second for Signatera in Japan, following a colorectal-cancer approval in June.
The company's chief medical officer, Alexey Aleshin, expressed optimism about the launch of the second Signatera MRD indication in Japan, which is scheduled for the first half of 2027. Natera's stock had already reached a 52-week high around $387-390 on Tuesday, bringing its market cap above $53 billion. The approval builds upon Natera's strong performance, with record sequential Signatera unit additions and a notable increase in revenue.
Currently, 9 out of 15 holdings in Natera's Healthcare Heroes strategy are positive, outperforming the S&P 500 Health Care index by 3.94 percentage points.
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