Unicycive Therapeutics, Inc. UNCY
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) is a cardio-renal-metabolic drug developer. Its lead program, Oxylanthanum carbonate (OLC), is in Phase 3 for Hyperphosphatemia in chronic kidney disease patients on dialysis.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Oxylanthanum carbonate (OLC) | Hyperphosphatemia in CKD patients on dialysis (505(b)(2) NDA; second CRL received 2026-06-30) | small molecule | Phase 3 |
| UNI-494 | Acute kidney injury | small molecule | Phase 1 |
Recent results and decisions
- Sep 29, 2026submitted Unicycive resubmitted the OLC NDA with CMC data from a new manufacturing vendor; FDA acceptance expected within 30 days and PDUFA about six months after resubmission.
today announced the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC)
Filing - Aug 12, 2026CRL FDA issued a CRL in June 2026 on the resubmitted OLC NDA citing the same third-party manufacturing deficiencies; no efficacy or safety concerns.
In June, the Company received a Complete Response Letter (CRL) from the FDA regarding the resubmitted NDA for OLC for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
Filing - Mar 30, 2026accepted FDA accepted the OLC NDA resubmission in January 2026 with a PDUFA target action date of June 29, 2026.
In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
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