pdufa.bio

Oxylanthanum Carbonate

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Oxylanthanum Carbonate is an Unicycive Therapeutics Inc. program in kidney disease. The FDA issued a Complete Response Letter on Jun 30, 2026. 1 FDA decision on record below. Every date links its source.

UNCY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Unicycive Therapeutics Inc. (UNCY). Market-cap tier at the time we tracked it: Micro. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

FDA decision · Jun 30, 2026 CRLUNCY

Questions

When is Oxylanthanum Carbonate's next FDA decision or readout?

No upcoming catalyst is on our calendar for Oxylanthanum Carbonate; 1 FDA decision is on record below.

What happened at Oxylanthanum Carbonate's most recent FDA decision?

On Jun 30, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.

Who makes Oxylanthanum Carbonate?

Unicycive Therapeutics Inc. (UNCY).

Has Oxylanthanum Carbonate been approved by the FDA?

Not in our records. The FDA issued a Complete Response Letter on Jun 30, 2026.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.