Roche wins FDA clearance for cobas BV/CV assay and EU backing for Susvimo eye implant

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โดย Simply Wall St·Read original
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Roche Holding received FDA clearance for its cobas BV/CV assay for diagnosing bacterial vaginosis and Candida vaginitis in the United States, while the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Susvimo, a ranibizumab eye implant, for neovascular age-related macular degeneration in Europe. The cobas BV/CV assay expands Roche's diagnostics portfolio, which already covers infectious disease, oncology, and other high-volume testing areas. Susvimo targets the large ophthalmology segment where treatment burden and visit frequency are key concerns. Roche shares trade at CHF367.9, about 1% above the consensus target of CHF363.9, and are flagged as undervalued, trading roughly 58.5% below Simply Wall St's fair value estimate. The stock has returned 9.5% over the past 30 days.

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FDA clearance for cobas BV/CV assay and EU CHMP recommendation for Susvimo eye implant

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