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Argenx, Calliditas Hit The Ground Running After FDA Approvals

Green Lights For Vyvant and Tarpeyo

Executive Summary

Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.

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Calliditas Eyes Full Approval For Tarpeyo In IgAN After Positive Pivotal Update

Data from part B of the Swedish firm’s pivotal trial of Tarpeyo in the rare kidney disorder showed that the treatment effects lasted two years across the entire population, enabling the move from conditional to full approvals in several markets.

Calliditas Confident Of Keeping Ahead Of Travere In IgAN

The Swedish group’s Tarpeyo is reaping the benefits of an expanded US sales force and the company is confident of a big revenue rise in 2023, regardless of new competition in the IgAN field from Travere’s Filspari.

Calliditas Spies Chinese Market As Tarpeyo Continues Upwards Sales Curve

The Swedish biotech’s successful launch in the US of Tarpeyo for immunoglobulin A nephropathy is progressing well and a Chinese approval is on the horizon as partner Everest’s application is accepted by regulators.

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