Calliditas: Secures a full approval with an improved label for Tarpeyo - Redeye

FDA has completed the review of Tarpeyo on time. With clear support from the 2-year post-approval study (NefIgArd Part B), Tarpeyo secures unconditional approval. Equally important is the label revision and, primarily, the broader label pointing to patients with a higher risk of rapid disease progression without referring to the previous 1.5 g/g UPCR limitation. The new label will support Tarpeyo’s market expansion. The timing is favorable as we await a new guideline draft from KDIGO within a month. We expect a positive >15% share market reaction compared with the local equity market.

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