Calliditas: FDA sticks to its gun and approves TARPEYO based on the primary endpoint
Research Note
2021-12-16
07:54
The TARPEYO approval comes after a non-material delay. The FDA decision is a conditional approval where the ongoing study NeflgArd Part B most likely need to show the ability to decline the inherent kidney function decline. In this respect, Redeye has a 95% LOS, which is probably a conservative take. The outcome is a positive breakthrough not only for Calliditas.
JU
Johan Unnerus
Disclosures and disclaimers