>
pdufa.bio

Oxylanthanum Carbonate

Updated ยทnext FDA decision on the calendar

Oxylanthanum Carbonate is a 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

Indication under review: Kidney disease. Sponsor: Unicycive Therapeutics Inc. (UNCY). Market-cap tier at the time we tracked it: Micro. We track 2 catalyst events for this program: 0 upcoming and 2 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

PDUFA · Jun 29, 2026UNCYPDUFA · 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.

What is Oxylanthanum Carbonate used for?

In our records Oxylanthanum Carbonate is under review or in development for Kidney disease.

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.