UNCY News

UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission

UNCY

LOS ALTOS, Calif., Jan. 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 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 Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.

January 29, 2026
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Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission

UNCY

LOS ALTOS, Calif., Jan. 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 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 Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026.

January 29, 2026
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Rosen Law Firm Urges Unicycive Therapeutics, Inc. (NASDAQ: UNCY) Stockholders with Large Losses to Contact the Firm for Information About Their Rights

UNCY

(NASDAQ:UNCY) NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces that a shareholder filed a class action on behalf of purchasers of securities of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) between March 29, 2024 and June 27, 2025, both dates inclusive (the “Class Period”). Unicycive is a clinical-stage biotechnology company. For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investigating

September 11, 2025Lawsuits
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Investors in Unicycive Therapeutics, Inc. Should Contact The Gross Law Firm Before October 14, 2025 to Discuss Your Rights - UNCY

UNCY

(NASDAQ:UNCY) NEW YORK, Sept. 11, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY). Shareholders who purchased shares of UNCY during the class period listed are encouraged to contact the firm regarding possible lead...

September 11, 2025Legal
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Shareholders that lost money on Unicycive Therapeutics, Inc.(UNCY) should contact The Gross Law Firm about pending Class Action - UNCY

UNCY

(NASDAQ:UNCY) NEW YORK, Sept. 4, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY). Shareholders who purchased shares of UNCY during the class period listed are encouraged to contact the firm regarding possible lead...

September 4, 2025Lawsuits
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Pomerantz Law Firm Announces the Filing of a Class Action Against Unicycive Therapeutics, Inc. and Certain Officers - UNCY

UNCY

(NASDAQ:UNCY) NEW YORK, Sept. 3, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) and certain officers. The class action, filed in the United States District Court Northern District...

September 3, 2025Lawsuits
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Investors who lost money on Unicycive Therapeutics, Inc.(UNCY) should contact The Gross Law Firm about pending Class Action - UNCY

UNCY

NEW YORK, Aug. 28, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY). Shareholders who purchased shares of UNCY during the class period listed are encouraged to contact the firm regarding possible lead...

August 28, 2025Lawsuits
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Pomerantz Law Firm Announces the Filing of a Class Action Against Unicycive Therapeutics, Inc. and Certain Officers - UNCY

UNCY

NEW YORK, Aug. 27, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) and certain officers. The class action, filed in the United States District Court Northern District...

August 27, 2025Lawsuits
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Unicycive Therapeutics to Participate in Upcoming Investor Events in September

UNCY

LOS ALTOS, Calif., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that Shalabh Gupta, M.D., Chief Executive Officer will participate in two investor events in September.

Pomerantz Law Firm Announces the Filing of a Class Action Against Unicycive Therapeutics, Inc. and Certain Officers - UNCY

UNCY

NEW YORK, Aug. 22, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) and certain officers. The class action, filed in the United States District Court Northern District...

August 22, 2025Lawsuits
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Unicycive Therapeutics, Inc. Sued for Securities Law Violations - Investors Should Contact Levi & Korsinsky Before October 14, 2025 to Discuss Your Rights - UNCY

UNCY

NEW YORK, Aug. 22, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Unicycive Therapeutics, Inc. ("Unicycive Therapeutics, Inc." or the "Company") (NASDAQ: UNCY) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of...

August 22, 2025Lawsuits
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Shareholders that lost money on Unicycive Therapeutics, Inc.(UNCY) Urged to Join Class Action - Contact The Gross Law Firm to Learn More

UNCY

NEW YORK, Aug. 21, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY). Shareholders who purchased shares of UNCY during the class period listed are encouraged to contact the firm regarding possible lead...

August 21, 2025Lawsuits
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Shareholders who lost money in shares of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) Should Contact Wolf Haldenstein Immediately.

UNCY

Lead Plaintiff Deadline is October 14, 2025 NEW YORK, Aug. 21, 2025 /PRNewswire/ -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all...

August 21, 2025Lawsuits
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UNCY INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Unicycive Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

UNCY

NEW YORK, Aug. 20, 2025 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or "the Company") (NASDAQ: UNCY) and...

August 20, 2025Lawsuits
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UNCY Investors Have Opportunity to Lead Unicycive Therapeutics, Inc. Securities Fraud Lawsuit with the Schall Law Firm

UNCY

LOS ANGELES--(BUSINESS WIRE)---- $UNCY--UNCY Investors Have Opportunity to Lead Unicycive Therapeutics, Inc. Securities Fraud Lawsuit with the Schall Law Firm

August 18, 2025Lawsuits
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SHAREHOLDER NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Unicycive Therapeutics

UNCY

NEW YORK--(BUSINESS WIRE)---- $UNCY #ClassAction--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) and reminds investors of the October 14, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Geor

August 18, 2025Lawsuits
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Investor Alert: Robbins LLP Informs Investors of the Unicycive Therapeutics, Inc. Class Action

UNCY

SAN DIEGO, Aug. 18, 2025 /PRNewswire/ -- Robbins LLP informs stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Unicycive Therapeutics, Inc. (NASDAQ: UNCY) securities between March 29, 2024 and June 27, 2025. Unicycive is a clinical-stage...

August 18, 2025Lawsuits
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Unicycive Therapeutics, Inc. - UNCY

UNCY

NEW YORK, Aug. 16, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The...

August 16, 2025Lawsuits
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Unicycive Therapeutics Stock Is Trading Lower Tuesday: What's Going On?

UNCY

Unicycive announced update on its NDA for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis.

June 10, 2025
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Unicycive Provides Update On New Drug Application for Oxylanthanum Carbonate To Treat Hyperphosphatemia In Patients With Chronic Kidney Disease On Dialysis; Says FDA to provide final decision by PDUFA Action Date Of June 28, 2025

UNCY

June 10, 2025
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HC Wainwright & Co. Assumes Unicycive Therapeutics at Buy, Announces Price Target of $9

UNCY

May 27, 2025
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Unicycive Therapeutics Q1 EPS $(0.05) Beats $(0.07) Estimate

UNCY

May 14, 2025
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Guggenheim Initiates Coverage On Unicycive Therapeutics with Buy Rating, Announces Price Target of $6

UNCY

April 21, 2025
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HC Wainwright & Co. Reiterates Buy on Unicycive Therapeutics, Maintains $7.5 Price Target

UNCY

April 11, 2025
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Unicycive Announces Presentation Of Patient-Reported Outcomes From Phase 2 OLC Study

UNCY

April 10, 2025
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HC Wainwright & Co. Maintains Buy on Unicycive Therapeutics, Raises Price Target to $7.5

UNCY

April 1, 2025
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Unicycive Therapeutics FY 2024 GAAP EPS $(0.56) Misses $(0.50) Estimate, As Of December 31, 2024, Cash And Cash Equivalents Of $26.1M, Sufficient To Fund Planned Operations Into 2026

UNCY

March 31, 2025
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Unicycive Therapeutics Reports Publication Of Preclinical Data In American Society Of Nephrology Journal, Kidney360

UNCY

February 20, 2025
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HC Wainwright & Co. Maintains Buy on Unicycive Therapeutics, Raises Price Target to $4

UNCY

November 14, 2024
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