Unicycive Therapeutics (UNCY) Company Report

The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) resubmission for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia, setting a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.
The company ended 2025 with an unaudited cash position of $41.3 million, which is expected to provide a cash runway into 2027.
Unicycive is advancing commercial preparation activities in anticipation of a potential OLC launch later in 2026.

Jan 29, 2026, 2:15 PM

Press Release

Unicycive Therapeutics Announces FDA Acceptance of OLC NDA Resubmission

UNCY

Product Launch

New Projects/Investments

Guidance Update

The FDA has accepted the resubmission of Unicycive Therapeutics' New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder, setting a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026.
Unicycive ended 2025 with an unaudited cash position of $41.3 million, providing an expected cash runway into 2027.
The company is advancing commercial preparation activities for a potential launch of OLC later in 2026, aiming to provide a treatment option for hyperphosphatemia in patients with chronic kidney disease on dialysis.

Jan 29, 2026, 12:05 PM

Press Release

Unicycive Therapeutics Resubmits NDA for Oxylanthanum Carbonate

UNCY

Product Launch

New Projects/Investments

Unicycive Therapeutics has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
The resubmission was made possible by the original third-party manufacturing vendor's progress in resolving FDA-cited deficiencies, which were the single issue identified in the Complete Response Letter (CRL) received in June 2025.
Unicycive currently has a cash runway into 2027.
FDA target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission and completion of submission review within 6 months.

Dec 29, 2025, 12:05 PM

Press Release

Unicycive Therapeutics Announces Q3 2025 Financial Results and OLC NDA Resubmission Plan

UNCY

Earnings

Guidance Update

New Projects/Investments

Unicycive Therapeutics, Inc. reported a net loss attributable to common stockholders of $6.0 million for the three months ended September 30, 2025.
For Q3 2025, Research and Development expenses were $3.0 million, and General and Administrative expenses were $4.4 million.
The company ended Q3 2025 with $42.7 million in cash and cash equivalents, providing an expected cash runway into 2027.
Unicycive remains on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year-end, with a potential new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026.

Nov 12, 2025, 2:12 PM

8-K

Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and OLC NDA Resubmission Plans

UNCY

Earnings

Guidance Update

Product Launch

Unicycive Therapeutics reported a net loss of $6.0 million for the three months ended September 30, 2025, compared to a net loss of $4.1 million for the same period in 2024.
As of September 30, 2025, the company held $42.7 million in cash and cash equivalents, with an expected cash runway into 2027.
The company remains on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year-end, with a potential Prescription Drug User Fee Act (PDUFA) date in the first half of 2026.
New analysis of OLC data presented at ASN Kidney Week 2025 demonstrated that OLC significantly reduced pill burden (7x in volume, 2x in count) compared to currently available phosphate binders.

Nov 12, 2025, 12:05 PM

Press Release

Unicycive Therapeutics Faces Shareholder Investigation Over Alleged Fiduciary Duty Breaches

UNCY

Legal Proceedings

Profit Warning

Bragar Eagel & Squire, P.C. is investigating Unicycive Therapeutics, Inc. (UNCY) on behalf of long-term stockholders who suffered losses between March 29, 2024, and June 27, 2025.
The investigation follows a class action complaint filed on August 15, 2025, alleging that Unicycive's board of directors may have breached their fiduciary duties.
The complaint claims Unicycive overstated its readiness to satisfy FDA manufacturing compliance requirements for its oxylanthanum carbonate (OLC) New Drug Application.
Unicycive's stock price fell over 40% on June 10, 2025, after the FDA identified cGMP deficiencies, and an additional almost 30% on June 30, 2025, following a Complete Response Letter for the OLC NDA.

Oct 31, 2025, 4:05 PM

Press Release

Unicycive Therapeutics to Present New Oxylanthanum Carbonate Data at ASN Kidney Week 2025

UNCY

Product Launch

New Projects/Investments

Unicycive Therapeutics (UNCY) will present new data on its investigational phosphate binder, oxylanthanum carbonate (OLC), at the American Society of Nephrology (ASN) Kidney Week 2025, taking place from November 5-9, 2025.
The data highlights that OLC led to clinically meaningful and statistically significant reductions in pill burden, decreasing the mean daily pill count from 8.3 to 3.9 and pill volume from 9.3 cm3 to 1.4 cm3 for dialysis patients with hyperphosphatemia.
OLC also improved serum phosphate control, with 91% of patients achieving ≤5.5 mg/dL at the end of the titration period, up from 59% at screening.
Unicycive aims to resubmit its New Drug Application (NDA) for OLC by year-end.

Oct 30, 2025, 11:05 AM

Press Release

Unicycive Therapeutics to Resubmit OLC NDA by Year-End Following FDA Meeting

UNCY

Product Launch

Guidance Update

New Projects/Investments

Unicycive Therapeutics, Inc. (UNCY) plans to resubmit the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) by year-end following a constructive FDA Type A meeting. The initial Complete Response Letter (CRL) on June 30, 2025, cited a single deficiency related to a third-party manufacturing vendor's compliance, with no other concerns identified.
The company anticipates a PDUFA date in the first half of 2026 for OLC after the NDA resubmission.
As of September 30, 2025, Unicycive reported approximately $42 million in cash and cash equivalents, providing a cash runway into 2027 to support the regulatory approval process and potential OLC commercialization.

Oct 28, 2025, 11:30 AM

8-K

Unicycive Therapeutics Provides FDA Meeting Update and Plans OLC NDA Resubmission

UNCY

Product Launch

Guidance Update

Unicycive Therapeutics held a Type A meeting with the FDA to address the single deficiency identified in the Complete Response Letter (CRL) for its Oxylanthanum Carbonate (OLC) New Drug Application (NDA), which was related to a third-party manufacturing vendor's compliance status.
The company plans to resubmit the OLC NDA by year-end, with a potential PDUFA date in the first half of 2026.
As of September 30, Unicycive reported over $42 million on its balance sheet, providing a cash runway into 2027.

Oct 28, 2025, 11:05 AM

Press Release

Unicycive Therapeutics faces class action lawsuit

UNCY

Legal Proceedings

Profit Warning

A class action lawsuit has been filed against Unicycive Therapeutics, Inc. (UNCY) and certain officers, alleging materially false and misleading statements regarding the company's ability to satisfy FDA manufacturing compliance requirements for its oxylanthanum carbonate (OLC) New Drug Application (NDA).
The class period for the lawsuit is between March 29, 2024, and June 27, 2025, with investors having until October 14, 2025, to seek appointment as Lead Plaintiff.
Unicycive's stock price fell 40.89% to $5.32 per share on June 10, 2025, after the FDA identified cGMP deficiencies, and an additional 29.85% to $4.77 per share on June 30, 2025, following a Complete Response Letter (CRL) for the OLC NDA.