Unicycive Therapeutics (UNCY) Company Report

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.

Oct 13, 2025, 6:34 PM

Press Release

Unicycive Therapeutics Faces Securities Class Action Lawsuit

UNCY

Legal Proceedings

Profit Warning

Faruqi & Faruqi, LLP is investigating Unicycive Therapeutics (NASDAQ: UNCY) for potential federal securities law violations, with a lead plaintiff deadline of October 14, 2025.
The complaint alleges that Unicycive overstated its ability to meet FDA manufacturing compliance requirements and the regulatory prospects of its OLC NDA.
Unicycive's stock price experienced significant drops: 40.89% on June 10, 2025, and an additional 29.85% on June 30, 2025, following disclosures of FDA-identified cGMP deficiencies and a subsequent Complete Response Letter for the OLC NDA.
Investors who incurred losses between March 29, 2024, and June 27, 2025, are encouraged to contact the law firm.

Oct 13, 2025, 4:23 PM

Press Release

Faruqi & Faruqi Investigates Unicycive Therapeutics for Securities Violations

UNCY

Legal Proceedings

Profit Warning

Faruqi & Faruqi, LLP is investigating Unicycive Therapeutics for potential federal securities law violations, alleging the company made false and/or misleading statements regarding its readiness to satisfy FDA manufacturing compliance requirements and the regulatory prospects of its OLC NDA.
Investors who suffered losses in Unicycive between March 29, 2024, and June 27, 2025, are encouraged to contact the firm, with the deadline to seek the role of lead plaintiff in the federal securities class action set for October 14, 2025.
The investigation follows significant stock price declines: a 40.89% drop on June 10, 2025, after Unicycive disclosed FDA-identified cGMP deficiencies at a third-party manufacturing vendor, and a further 29.85% fall on June 30, 2025, when the FDA issued a Complete Response Letter for the OLC NDA citing these deficiencies.

Oct 12, 2025, 12:52 PM

Press Release

Unicycive Therapeutics Faces Securities Class Action Investigation

UNCY

Legal Proceedings

Faruqi & Faruqi, LLP is investigating Unicycive Therapeutics (UNCY) for alleged federal securities law violations, with a October 14, 2025 deadline for investors who purchased securities between March 29, 2024, and June 27, 2025, to seek lead plaintiff status.
The complaint alleges that Unicycive overstated its readiness to satisfy FDA manufacturing compliance requirements and the regulatory prospects of its OLC NDA.
Unicycive's stock price fell 40.89% to $5.32 per share on June 10, 2025, after disclosing FDA cGMP deficiencies, and further dropped 29.85% to $4.77 per share on June 30, 2025, following a Complete Response Letter for the OLC NDA.