UniCycive Therapeutics Inc (UNCY)

[Whalatane]

Unicycive to refile OLC NDA by year-end after FDA Type A meeting confirmed only a vendor issue in CRL;
EU inspection found no deficiencies.
PDUFA decision expected 1H 2026.

if this is accurate ...big positive

theres roughly the same dialysis population in the EU / UK needing a better serum pho pill ...as in the US .
Co needs to detail their plans for the EU / UK especially if EU found no deficiencies .
Theres also no TDAPA , dialysis bundle in the EU / UK and some feel better govt care for dialysis patients than in the US .
Co needs to detail their plans for this market

Kiwi