Unicycive Therapeutics, Inc.

Case Overview
48 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 10/14/2025 |
Status: | Status: Investigating |
Company Name: | Company Name: Unicycive Therapeutics, Inc. |
Court: | Court: Northern District of California |
Case Number: | Case Number: 3:25cv06923 |
Class Period: | Class Period: 03/29/2024 - 06/27/2025 |
Ticker: | Ticker: UNCY |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ:UNCY) securities during the period of March 29, 2024 through June 27, 2025, inclusive (“the Class Period”). If you suffered a loss on your Unicycive investments, you have until October 14, 2025 to request lead plaintiff appointment.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i)Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times.
On June 10, 2025, Unicycive issued a press release "announcing an update on its [NDA] for [OLC] to treat hyperphosphatemia in patients with [CKD] on dialysis." Therein, the Company disclosed that the FDA "had identified deficiencies in cGMP [current good manufacturing practice] compliance at a third-party manufacturing vendor"-specifically, a third-party subcontractor of Unicycive's contract development and manufacturing organization ("CDMO")-"following an FDA inspection" and that, "given the identified deficiencies, any label discussions between the FDA and the Company are precluded." On this news, Unicycive's stock price fell $3.68 per share, or 40.89%, to close at $5.32 per share on June 10, 2025.
Then, on June 30, 2025, Unicycive issued a press release announcing that the FDA had issued a Complete Response Letter for the OLC NDA, citing the previously identified cGMP deficiencies at the third-party subcontractor of its CDMO. On this news, Unicycive's stock price fell $2.03 per share, or 29.85%, to close at $4.77 per share on June 30, 2025.that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i)Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times.
On June 10, 2025, Unicycive issued a press release "announcing an update on its [NDA] for [OLC] to treat hyperphosphatemia in patients with [CKD] on dialysis." Therein, the Company disclosed that the FDA "had identified deficiencies in cGMP [current good manufacturing practice] compliance at a third-party manufacturing vendor"-specifically, a third-party subcontractor of Unicycive's contract development and manufacturing organization ("CDMO")-"following an FDA inspection" and that, "given the identified deficiencies, any label discussions between the FDA and the Company are precluded." On this news, Unicycive's stock price fell $3.68 per share, or 40.89%, to close at $5.32 per share on June 10, 2025.
Then, on June 30, 2025, Unicycive issued a press release announcing that the FDA had issued a Complete Response Letter for the OLC NDA, citing the previously identified cGMP deficiencies at the third-party subcontractor of its CDMO. On this news, Unicycive's stock price fell $2.03 per share, or 29.85%, to close at $4.77 per share on June 30, 2025.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i)Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times.
On June 10, 2025, Unicycive issued a press release "announcing an update on its [NDA] for [OLC] to treat hyperphosphatemia in patients with [CKD] on dialysis." Therein, the Company disclosed that the FDA "had identified deficiencies in cGMP [current good manufacturing practice] compliance at a third-party manufacturing vendor"-specifically, a third-party subcontractor of Unicycive's contract development and manufacturing organization ("CDMO")-"following an FDA inspection" and that, "given the identified deficiencies, any label discussions between the FDA and the Company are precluded." On this news, Unicycive's stock price fell $3.68 per share, or 40.89%, to close at $5.32 per share on June 10, 2025.
Then, on June 30, 2025, Unicycive issued a press release announcing that the FDA had issued a Complete Response Letter for the OLC NDA, citing the previously identified cGMP deficiencies at the third-party subcontractor of its CDMO. On this news, Unicycive's stock price fell $2.03 per share, or 29.85%, to close at $4.77 per share on June 30, 2025.that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i)Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times.
On June 10, 2025, Unicycive issued a press release "announcing an update on its [NDA] for [OLC] to treat hyperphosphatemia in patients with [CKD] on dialysis." Therein, the Company disclosed that the FDA "had identified deficiencies in cGMP [current good manufacturing practice] compliance at a third-party manufacturing vendor"-specifically, a third-party subcontractor of Unicycive's contract development and manufacturing organization ("CDMO")-"following an FDA inspection" and that, "given the identified deficiencies, any label discussions between the FDA and the Company are precluded." On this news, Unicycive's stock price fell $3.68 per share, or 40.89%, to close at $5.32 per share on June 10, 2025.
Then, on June 30, 2025, Unicycive issued a press release announcing that the FDA had issued a Complete Response Letter for the OLC NDA, citing the previously identified cGMP deficiencies at the third-party subcontractor of its CDMO. On this news, Unicycive's stock price fell $2.03 per share, or 29.85%, to close at $4.77 per share on June 30, 2025.