# Oxylanthanum carbonate (OLC) PDUFA Event: Hyperphosphatemia in chronic kidney disease

Canonical URL: https://biopharmsignal.com/pdufa-calendar/UNCY/oxylanthanum-carbonate-hyperphosphatemia-review-2

Ticker: UNCY

Company: Unicycive Therapeutics

Event date: 2026-06-29

Event type: FDA Decision

Stage: PDUFA

Result: Complete Response Letter

Result date: 2026-06-30

Application type: NDA

Review cycle: 2

FDA issued a second Complete Response Letter. The CRL cited the same unresolved deficiencies at a third-party manufacturing vendor identified in the first re...

## Event Timeline

### June 30, 2026 — FDA issued a second Complete Response Letter

The CRL cited the same unresolved deficiencies at a third-party manufacturing vendor identified in the first review cycle. FDA raised no concerns about OLC clinical efficacy or safety and requested no additional clinical data.

[Unicycive — OLC resubmission Complete Response Letter](https://ir.unicycive.com/news/detail/123/unicycive-therapeutics-receives-complete-response-letter)

### January 29, 2026 — FDA accepted the NDA resubmission

FDA classified the filing as a Class 2 complete response and assigned a late-June 2026 target action date.

[Unicycive — OLC NDA resubmission acceptance](https://ir.unicycive.com/news/detail/117/unicycive-therapeutics-announces-fda-acceptance-of)

### December 29, 2025 — Unicycive resubmitted the NDA

Unicycive resubmitted the application after addressing the manufacturing issue discussed with FDA following the first-cycle CRL.

[Unicycive — OLC regulatory history and resubmission](https://ir.unicycive.com/news)

### June 30, 2025 — FDA issued the first Complete Response Letter

The first-cycle CRL concerned deficiencies at a third-party manufacturing vendor and did not identify deficiencies in the submitted preclinical, clinical or safety data.

[Unicycive — First OLC Complete Response Letter](https://d1io3yog0oux5.cloudfront.net/_688b40276f79816531811e483aed0b5c/unicycive/news/2025-06-30_Unicycive_Therapeutics_Announces_Receipt_of_104.pdf)

## Related Pages

- UNCY PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/UNCY.md

- UNCY company profile: https://biopharmsignal.com/company/UNCY.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-09-01 — Unicycive Therapeutics to Present at the H.C. Wainwright 28th Annual Global Investment Conference: https://biopharmsignal.com/news/UNCY/unicycive-therapeutics-to-present-at-the-h-c-wainwright-28th-annual-global-inves-625af9dc.md

- 2026-08-12 — Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update: https://biopharmsignal.com/news/UNCY/unicycive-therapeutics-announces-second-quarter-2026-financial-results-and-provi-adb5adad.md

- 2026-06-30 — Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA): https://biopharmsignal.com/news/UNCY/unicycive-therapeutics-receives-complete-response-letter-from-fda-regarding-resu-2c152ab0.md

- 2026-05-12 — Unicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update: https://biopharmsignal.com/news/UNCY/unicycive-therapeutics-announces-first-quarter-2026-financial-results-and-provides-business-update.md

- 2026-04-09 — Unicycive Therapeutics to Present at the 25th Annual Needham Virtual Healthcare Conference: https://biopharmsignal.com/news/UNCY/unicycive-therapeutics-to-present-at-the-25th-annual-needham-virtual-healthcare-conference.md