Calliditas: Secures a full approval with an improved label for Tarpeyo
Research Note
2023-12-21
06:11
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.
Johan Unnerus
Disclosures and disclaimers