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Form 3 Unicycive Therapeutics, For: Oct 01 Filed by: Manning Meredith

Thu, 01 Oct 2026 16:30:00 -0400

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Unicycive Therapeutics adds Meredith Manning to its board

Thu, 01 Oct 2026 07:05:26 -0400

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) has appointed Meredith Manning, M.B.A., to its board of directors, according to a company statement. Manning will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees, and will chair the Nominating and Corporate Governance Committee.

Manning brings more than 25 years of biopharmaceutical experience to the role. Most recently, she served as Chief Commercial Officer of Soleno Therapeutics, Inc. from 2024 until its acquisition by Neurocrine Biosciences, Inc. in 2026, where she built the commercial organization and led the U.S. launch of VYKAT XR, an FDA-approved treatment for hyperphagia in Prader-Willi syndrome.

Before Soleno, Manning

Unicycive Therapeutics Appoints Meredith Manning to Board of Directors

Thu, 01 Oct 2026 07:05:00 -0400

MOUNTAIN VIEW, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the appointment of Meredith Manning, M.B.A., to its Board of Directors.

“We are very pleased to welcome Meredith to our Board of Directors. Her extensive commercialization experience, track record of building successful biopharmaceutical organizations, and leadership through successful product launches will be invaluable to Unicycive,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics. “We look forward to benefiting from Meredith’s strategic insight

Unicycive Therapeutics Appoints Meredith Manning to Board of Directors

Thu, 01 Oct 2026 07:05:00 -0400

UNCY LAWSUIT: Unicycive Therapeutics Investors Should Contact Block & Leviton to Possibly Recover Losses

Tue, 29 Sep 2026 15:21:00 -0400

Boston, Massachusetts--(Newsfile Corp. - September 29, 2026) - Block & Leviton reminds investors that a securities fraud lawsuit has been filed against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and certain of its executives. Investors who have lost money in their Unicycive Therapeutics 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?

On June 30, 2026, Unicycive Therapeutics disclosed that the FDA had issued a second Complete Response Letter, declining to approve OLC based on the same manufacturing deficiencies identified a year earlier. The company also stated

UNCY LAWSUIT: Unicycive Therapeutics Investors Should Contact Block & Leviton to Possibly Recover Losses

Tue, 29 Sep 2026 15:21:00 -0400

What is this all about?

Form 8-K Unicycive Therapeutics, For: Sep 28

Tue, 29 Sep 2026 07:46:00 -0400

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Unicycive resubmits NDA for kidney disease drug with new manufacturer

Tue, 29 Sep 2026 07:05:28 -0400

Unicycive Therapeutics (Nasdaq: UNCY) announced Sept. 29, 2026, the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

The resubmission includes Chemistry, Manufacturing, and Controls (CMC) data from a new third-party drug product manufacturing vendor. That vendor's facility was last inspected by the FDA in March 2024 and received "No Action Indicated" status, indicating compliance with current Good Manufacturing Practices. The new vendor has completed 12-month stability studies on OLC drug product, and the resubmission also includes additional in-vitro bridging data between the

Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate

Tue, 29 Sep 2026 07:05:00 -0400

Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor
The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor
Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission
Current cash position allows runway into 2H 2027

MOUNTAIN VIEW, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced

Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate

Tue, 29 Sep 2026 07:05:00 -0400

Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor
The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor
Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission
Current cash position allows runway into 2H 2027

Form 8-K Unicycive Therapeutics, For: Sep 03

Mon, 28 Sep 2026 16:31:00 -0400

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Unicycive Therapeutics (UNCY) PT Raised to $15 at Benchmark Following Q2 Results

Thu, 20 Aug 2026 09:20:30 -0400

(Updated - August 20, 2026 9:20 AM EDT)

Benchmark analyst Bruce Jackson raised the price target on Unicycive Therapeutics (NASDAQ: UNCY) to $15.00 (from $13.00) while maintaining a Speculative Buy rating.

The analyst commented, "We are updating our model for 2Q results. Recall that on June 30 Unicycive received a second 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

Unicycive Therapeutics (UNCY) PT Raised to $15 at Benchmark Following Q2 Results

Thu, 20 Aug 2026 09:20:30 -0400

(Updated - August 20, 2026 9:20 AM EDT)

Benchmark analyst Bruce Jackson raised the price target on Unicycive Therapeutics (NASDAQ: UNCY) to $15.00 (from $13.00) while maintaining a Speculative Buy rating.

Form SCHEDULE 13G/A Unicycive Therapeutics, Filed by: Nantahala Capital Management, LLC

Fri, 14 Aug 2026 16:46:00 -0400

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Form SCHEDULE 13G/A Unicycive Therapeutics, Filed by: Nantahala Capital Management, LLC

Fri, 14 Aug 2026 16:46:00 -0400

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Form SCHEDULE 13G/A Unicycive Therapeutics, Filed by: Vivo Opportunity Fund Holdings, L.P.

Fri, 14 Aug 2026 16:20:00 -0400

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Form SCHEDULE 13G/A Unicycive Therapeutics, Filed by: Vivo Opportunity Fund Holdings, L.P.

Fri, 14 Aug 2026 16:20:00 -0400

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Unicycive Therapeutics (UNCY) PT Lowered to $20 at B.Riley

Thu, 13 Aug 2026 08:59:54 -0400

B.Riley lowered its price target on Unicycive Therapeutics (NASDAQ: UNCY) to $20.00 (from $22.00) while maintaining a Buy rating.

Unicycive Therapeutics (UNCY) PT Lowered to $25 at Guggenheim

Thu, 13 Aug 2026 06:48:20 -0400

(Updated - August 13, 2026 6:48 AM EDT)

Guggenheim analyst Vamil Divan lowered the price target on Unicycive Therapeutics (NASDAQ: UNCY) to $25.00 (from $37.00) while maintaining a Buy rating.

The analyst commented: "Unicycive released 2Q 2026 results and provided a corporate update earlier today. Unfortunately, the wait continues for the FDA to inspect the subcontractor manufacturing site that is responsible for the company receiving a second Complete Response Letter for oxylanthanum carbonate (OLC) on June 29th. We spoke to management this morning, and they said they have been in close contact with the FDA on the issue and continue to believe

Unicycive Therapeutics (UNCY) PT Lowered to $25 at Guggenheim

Thu, 13 Aug 2026 06:48:20 -0400

(Updated - August 13, 2026 6:48 AM EDT)

Guggenheim analyst Vamil Divan lowered the price target on Unicycive Therapeutics (NASDAQ: UNCY) to $25.00 (from $37.00) while maintaining a Buy rating.

Form 8-K Unicycive Therapeutics, For: Aug 12

Wed, 12 Aug 2026 08:04:00 -0400

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Form 8-K Unicycive Therapeutics, For: Aug 12

Wed, 12 Aug 2026 08:04:00 -0400

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Unicycive Therapeutics, Inc (UNCY) Tops Q2 EPS by 42c

Wed, 12 Aug 2026 07:35:20 -0400

Unicycive Therapeutics, Inc (NASDAQ: UNCY) reported Q2 EPS of ($0.06), $0.42 better than the analyst estimate of ($0.48).

For earnings history and earnings-related data on Unicycive Therapeutics, Inc (UNCY) click here.

Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update

Wed, 12 Aug 2026 07:19:00 -0400

- Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor

- FDA has assigned a facility inspection to third-party manufacturing vendor of OLC

- As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027

MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended

Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update

Wed, 12 Aug 2026 07:19:00 -0400

- Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor

- FDA has assigned a facility inspection to third-party manufacturing vendor of OLC

- As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027