Unicycive Therapeutics (UNCY) catalysts

Upcoming FDA decisions and readouts we track for Unicycive Therapeutics, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 07 Oct 2026

FreeBioList tracks 1 upcoming catalyst for Unicycive Therapeutics (UNCY, listed on Nasdaq). It concerns Oxylanthanum carbonate (OLC) (Hyperphosphatemia in CKD patients on dialysis).

First on the list: the PDUFA date for Oxylanthanum carbonate (OLC) (Hyperphosphatemia in CKD patients on dialysis), guided by the company to Mar 2027 (expected).

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 07 Oct 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: UNCY
Next catalyst: Mar 2027 (expected)
Type: PDUFA date
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Unicycive Therapeutics UNCY · Nasdaq	Oxylanthanum carbonate (OLC)	Hyperphosphatemia in CKD patients on dialysis	Mar 2027 (expected) company guidance	PDUFA date	Verified	8-K exhibit 99.1 ↗	Yes
Notes — NDA resubmitted 29 Sep 2026. Filing states the company "anticipates ... a new assigned PDUFA date to be six months from the date of resubmission", i.e. about late March 2027. The FDA had not yet assigned the date. Update when acceptance is announced. Source: 8-K exhibit 99.1, filed 29 Sep 2026 · verified 07 Oct 2026

Also due in Q1 2027

Pharming Group (PHAR)PDUFA date for Leniolisib (Joenja) lower doses, 30 Jan 2027
Belite Bio (BLTE)PDUFA date for Tinlarebant, 12 Feb 2027
Takeda Pharmaceutical (TAK)PDUFA date for Zasocitinib (TAK-279), Q1 2027
Arcutis Biotherapeutics (ARQT)PDUFA date for ZORYVE (roflumilast) cream 0.05%, 23 Feb 2027
Intellia Therapeutics (NTLA)PDUFA date for Lonvoguran ziclumeran (lonvo-z), 10 Mar 2027
Apnimed (APMD)PDUFA date for AD109 (Oxnimbi), 28 Feb 2027