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FDA accepts Unicycive's OLC resubmission with March 2027 action date

Thu, 22 Oct 2026 13:14:14 -0400

Unicycive Therapeutics (NASDAQ: UNCY) announced that the U.S. Food and Drug Administration has accepted the resubmission of its New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for treating hyperphosphatemia in patients with chronic kidney disease on dialysis.

The FDA classified the resubmission as Class II, triggering a six-month review period and setting a Prescription Drug User Fee Act target action date of March 25, 2027.

The resubmission follows a Complete Response Letter the company received in June 2026. The original NDA was rejected due to deficiencies at the company's third-party drug product manufacturer, which the FDA had not

Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate NDA Resubmission and PDUFA Date of March 25, 2027

Thu, 22 Oct 2026 12:00:00 -0400

Mountain View, CA, Oct 23, 2026 - (JCN Newswire) - - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II

FDA accepts Unicycive's OLC drug resubmission with March 2027 review date

Wed, 21 Oct 2026 21:31:47 -0400

Unicycive Therapeutics (Nasdaq: UNCY) announced that the U.S. Food and Drug Administration has accepted the resubmission of its New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis.

The FDA classified the resubmission as Class II, setting a Prescription Drug User Fee Act target action date of March 25, 2027, reflecting a six-month review period from the resubmission date.

The resubmission followed a Complete Response Letter issued in June 2026, which cited deficiencies at the original third-party drug product manufacturer that the FDA had not been able to re-inspect during

FDA accepts Unicycive's OLC resubmission, sets March 2027 review date

Wed, 21 Oct 2026 19:59:28 -0400

The FDA classified the resubmission as Class II, triggering a six-month review period and setting a Prescription Drug User Fee Act target action date of March 25, 2027.

The resubmission follows a Complete Response Letter issued in June 2026, which cited deficiencies at the original third-party drug product manufacturer that the FDA had not been able to re-inspect during the prior submission

Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate NDA Resubmission and PDUFA Date of March 25, 2027

Wed, 21 Oct 2026 19:00:00 -0400

Mountain View, CA, Oct 22, 2026 - (JCN Newswire) - - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II

Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate NDA Resubmission and PDUFA Date of March 25, 2027

Wed, 21 Oct 2026 18:30:00 -0400

Mountain View, CA, Oct 22, 2026 - (ACN Newswire) - - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II

Unicycive stock jumps as FDA accepts OLC drug resubmission

Wed, 21 Oct 2026 09:33:42 -0400

Investing.com -- Unicycive Therapeutics Inc (NASDAQ:UNCY) shares rose 6.8% in premarket trading Wednesday after the U.S. Food and Drug Administration accepted the resubmission of its New Drug Application for oxylanthanum carbonate, an investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis.

The FDA classified the OLC resubmission as Class II with a six-month review period and set a Prescription Drug User Fee Act target action date of March 25, 2027. The resubmission follows a Complete Response Letter received in June 2026.

The resubmission includes Chemistry, Manufacturing, and Controls data from a new third-party drug

Unicycive stock jumps as FDA accepts OLC drug resubmission

Wed, 21 Oct 2026 09:33:42 -0400

The resubmission includes Chemistry, Manufacturing, and Controls data from a new third-party drug

FDA accepts Unicycive's OLC drug resubmission, sets March 2027 review date

Wed, 21 Oct 2026 07:05:15 -0400

The FDA classified the resubmission as a Class II review with a six-month review period, setting a Prescription Drug User Fee Act target action date of March 25, 2027.

The resubmission follows a Complete Response Letter the company received in June 2026, which cited deficiencies at the original third-party drug product manufacturer that the FDA had not been able to re-inspect

Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027

Wed, 21 Oct 2026 07:05:00 -0400

Resubmission includes Chemistry, Manufacturing, and Controls (CMC) data from new drug product (DP) manufacturing vendor

MOUNTAIN VIEW, Calif., Oct. 21, 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 that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete

Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027

Wed, 21 Oct 2026 07:05:00 -0400

Resubmission includes Chemistry, Manufacturing, and Controls (CMC) data from new drug product (DP) manufacturing vendor

INVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Unicycive Therapeutics, Inc. to Contact Law Firm

Tue, 20 Oct 2026 16:17:00 -0400

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) shareholders should email fletcher@fmoorelaw.com

NEW YORK, Oct. 20, 2026 /PRNewswire/ --

INVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Unicycive Therapeutics, Inc. to Contact Law Firm

Tue, 20 Oct 2026 16:17:00 -0400

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) shareholders should email fletcher@fmoorelaw.com

NEW YORK, Oct. 20, 2026 /PRNewswire/ --

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

si-local-file:///var/storage/secattach/20260929/27117506.html

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