- CARA's IV Korsuva for the treatment of severe itching (pruritus) in CKD patients on dialysis has a PDUFA date of August 23, 2021.
- It appears that the FDA does not have issues with IV Korsuva's safety and efficacy, but the remaining NDA approval risks appear to be mainly potential CMC issues.
- The CMC risk appears lower because Korsuva is a peptide, but higher because Korsuva has never been approved by the FDA and CARA has no approved drugs.
- Abuse potential liability scheduling needs to be addressed by the FDA too, which investors need to consider. The agreements with Vifor/Fresenius give us more confidence as long-term investors in CARA.
- Oral Korsuva provides a lot of upside potential long term, without a lot of short-term risk, since CARA stock recently took a big hit from its last oral Korsuva readout in April 2021. We currently plan to hold our CARA positions through the upcoming PDUFA readout.
For further details see:
Cara And IV Korsuva: Key Bull And Bear Investor Thoughts Going Into Upcoming PDUFA