That Ginko Bio is everywhere- we want to keep track of the Spac that is getting that-- How did Bill Ack miss this! Going to be huge.
CARA alert** Feeling Itchy?
Fri up 10% to $13.70
Pre market up again to $14.68
The FDA action date on Cara Therpeutics'(NASDAQ:CARA)Korsuva is also on tap. An approval means the company can move forward with plans to launch products this year with a commercial partner already lined up. Analysts tip that CARA could see a significant share price move when the FDA announcement is made.
Summary
CARA alert** Feeling Itchy?
Fri up 10% to $13.70
Pre market up again to $14.68
The FDA action date on Cara Therpeutics'(NASDAQ:CARA)Korsuva is also on tap. An approval means the company can move forward with plans to launch products this year with a commercial partner already lined up. Analysts tip that CARA could see a significant share price move when the FDA announcement is made.
Summary
- 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.
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