Delay For Calliditas Kidney Drug Not Major Cause For Concern
FDA Extends Review For Nefecon
Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.
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The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.
The Swedish biotech’s oral corticosteroid for a kidney disorder has left the EMA’s CHMP with questions on its manufacturing, delaying an EU approval opinion that had been slated for the first quarter.
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to experimental products from Atara, Calliditas, and Roche.