StreetInsider.com News Articles

Form SCHEDULE 13G/A Unicycive Therapeutics, Filed by: INTEGRATED CORE STRATEGIES (US) LLC

Wed, 08 Jul 2026 17:51:00 -0400

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Form SCHEDULE 13G/A Unicycive Therapeutics, Filed by: INTEGRATED CORE STRATEGIES (US) LLC

Wed, 08 Jul 2026 17:51:00 -0400

si-local-file:///var/storage/secattach/20260708/26748502.html

Unicycive Therapeutics ALERT: Securities Fraud Investigation by Block & Leviton Could Allow Investors to Recover Losses

Mon, 06 Jul 2026 08:42:00 -0400

Boston, Massachusetts--(Newsfile Corp. - July 6, 2026) - Block & Leviton is investigating Unicycive Therapeutics, Inc. (NASDAQ: UNCY) for potential securities law violations. Investors who have lost money in their Unicycive Therapeutics, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/uncy.

What is this all about?

Block & Leviton is investigating whether Unicycive Therapeutics made false or misleading statements to investors or failed to disclose material information about the FDA review of its OLC New Drug Application. On June 30, 2026, Unicycive announced that the FDA had issued a

Unicycive Therapeutics ALERT: Securities Fraud Investigation by Block & Leviton Could Allow Investors to Recover Losses

Mon, 06 Jul 2026 08:42:00 -0400

What is this all about?

Form 8-K Unicycive Therapeutics, For: Jul 02

Thu, 02 Jul 2026 10:30:00 -0400

si-local-file:///var/storage/secattach/20260702/26725227.html

Form 8-K Unicycive Therapeutics, For: Jul 02

Thu, 02 Jul 2026 10:30:00 -0400

si-local-file:///var/storage/secattach/20260702/26725227.html

UNCY INVESTIGATION ALERT: Investors Who Lost Money in Unicycive Therapeutics, Inc. Should Contact Block & Leviton

Thu, 02 Jul 2026 08:45:00 -0400

Boston, Massachusetts--(Newsfile Corp. - July 2, 2026) - Block & Leviton is investigating Unicycive Therapeutics, Inc. (NASDAQ: UNCY) for potential securities law violations. Investors who have lost money in their Unicycive Therapeutics, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/uncy.

What is this all about?

UNCY INVESTIGATION ALERT: Investors Who Lost Money in Unicycive Therapeutics, Inc. Should Contact Block & Leviton

Thu, 02 Jul 2026 08:45:00 -0400

What is this all about?

Form 144 Unicycive Therapeutics, Filed by: Vivo Opportunity Fund Holdings, L.P.

Wed, 01 Jul 2026 17:48:00 -0400

si-local-file:///var/storage/secattach/20260701/26722313.html

Form 144 Unicycive Therapeutics, Filed by: Vivo Opportunity Fund Holdings, L.P.

Wed, 01 Jul 2026 17:48:00 -0400

si-local-file:///var/storage/secattach/20260701/26722313.html

Unicycive Therapeutics (UNCY) PT Lowered to $13 at Benchmark on OLC Rejection

Wed, 01 Jul 2026 07:27:08 -0400

Benchmark analyst Bruce Jackson lowered the price target on Unicycive Therapeutics (NASDAQ: UNCY) to $13.00 (from $18.00) while maintaining a Speculative Buy rating.

The analyst commented, "Unicycive Therapeutics said it received a new Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for oxylanthanum carbonate (OLC), and once again the rejection is related to a deficiency at a third-party manufacturing vendor employed by its CDMO. The company noted that it is in active and ongoing discussion with the FDA regarding the label and packaging, and remains optimistic about an inspection of the third-party manufacturing vendor in the

Unicycive Therapeutics (UNCY) PT Lowered to $13 at Benchmark on OLC Rejection

Wed, 01 Jul 2026 07:27:08 -0400

Benchmark analyst Bruce Jackson lowered the price target on Unicycive Therapeutics (NASDAQ: UNCY) to $13.00 (from $18.00) while maintaining a Speculative Buy rating.

Increasing unusual option volume: UNM CGNX UNCY CNXC NN DOMO JACK SOLS KSTR

Tue, 30 Jun 2026 10:46:09 -0400

Increasing unusual option volume: UNM CGNX UNCY CNXC NN DOMO JACK SOLS KSTR

FDA issues second complete response letter to Unicycive over OLC drug application

Tue, 30 Jun 2026 07:05:18 -0400

Unicycive Therapeutics (Nasdaq: UNCY) announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding the resubmitted New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis.

The CRL cites the same third-party manufacturing deficiencies identified in a previous CRL issued in June 2025. According to the company, the FDA did not conduct an inspection of the third-party manufacturing vendor during the review period of the resubmitted NDA. The FDA did not raise concerns about the clinical efficacy or safety of OLC, and no

FDA issues second complete response letter to Unicycive over OLC drug application

Tue, 30 Jun 2026 07:05:18 -0400

FDA issues second complete response letter to Unicycive over OLC drug application

Tue, 30 Jun 2026 07:05:18 -0400

FDA issues second complete response letter to Unicycive over OLC drug application

Tue, 30 Jun 2026 07:05:18 -0400

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Tue, 30 Jun 2026 07:05:00 -0400

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor --

-- FDA inspection of third-party facility did not occur during the NDA resubmission review --

-- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label --

-- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested --

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology