Unicycive Therapeutics, Inc.UNCYNASDAQ

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seekingalpha.com

Unicycive: 'Buy' Rating On NDA Resubmission OLC And Potential Best-In-Class Profile

I initiate Unicycive Therapeutics with a "Buy" rating, driven by the FDA's acceptance of its OLC NDA resubmission and a defined PDUFA date. OLC targets hyperphosphatemia in CKD dialysis patients, offering competitive advantages like lower pill burden, smaller size, and swallowable tablets. The prior FDA rejection was solely due to third-party manufacturing issues, not clinical data, increasing confidence in potential approval.

globenewswire.com

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

FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026 Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027 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.

globenewswire.com

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

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.

globenewswire.com

Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)

New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission

newsfilecorp.com

Important Notice to Long-term Shareholders of Unicycive Therapeutics, Inc. (UNCY): Grabar Law Office Is Investigating Claims on Your Behalf

Philadelphia, Pennsylvania--(Newsfile Corp. - December 1, 2025) - Grabar Law Office is investigating claims on behalf of shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY). The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company.

globenewswire.com

Unicycive Therapeutics to Participate in Upcoming Investor Events in December

LOS ALTOS, Calif., Nov. 25, 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 December.

globenewswire.com

Bragar Eagel & Squire is Investigating Certain Officers and Directors of Quantum, Unicycive, Fly-E, and Lantheus on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel and Squire, P. C. , a nationally recognized shareholder rights law firm, is investigating certain officers and directors Quantum Corporation (NASDAQ: QMCO), Unicycive Therapeutics, Inc. (NASDAQ: UNCY), Fly-E Group, Inc.

globenewswire.com

Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update

- Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end - Presented new analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count (2x) compared to currently available phosphate binders - Ended Q3 with $42.7 million of cash with expected runway into 2027 LOS ALTOS, Calif., Nov. 12, 2025 (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 its financial results for the three months ended September 30, 2025, and provided a business update.

globenewswire.com

Unicycive Therapeutics to Participate in a Fireside Chat at the Guggenheim 2nd Annual Healthcare Innovation Conference

LOS ALTOS, Calif., Nov. 03, 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 a fireside chat at the Guggenheim 2nd Annual Healthcare Innovation Conference on Monday, November 10, 2025, at 3:30 p.m. ET.

globenewswire.com

UNICYCIVE ALERT: Bragar Eagel & Squire, P.C. is Investigating Unicycive Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Defendants allegedly overstated Unicycive's FDA readiness for its OLC NDA; later cGMP issues at a subcontractor led to FDA setbacks and stock drops.

globenewswire.com

Unicycive Therapeutics Announces Upcoming Presentation of New Data Reinforcing the Potential of Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia at the American Society of Nephrology Kidney Week 2025 Conference

Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapy Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapy

globenewswire.com

Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End

Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC

businesswire.com

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

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.

prnewswire.com

UNCY Investors Have Opportunity to Lead Unicycive Therapeutics, Inc. Securities Fraud Lawsuit

NEW YORK , Oct. 14, 2025 /PRNewswire/ -- Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) between March 29, 2024 and June 27, 2025, both dates inclusive (the "Class Period"), of the important October 14, 2025 lead plaintiff deadline. So what: If you purchased Unicycive securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

prnewswire.com

Unicycive Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - UNCY

LOS ANGELES , Oct. 13, 2025 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against Unicycive Therapeutics, Inc. ("Unicycive" or "the Company") (NASDAQ: UNCY ) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Shareholders who purchased shares of UNCY during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments.

prnewswire.com

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

LOS ANGELES , Oct. 13, 2025 /PRNewswire/ -- The Schall Law Firm , a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Unicycive Therapeutics, Inc. ("Unicycive" or "the Company") (NASDAQ: UNCY) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between March 29, 2024 and June 27, 2025, inclusive (the "Class Period"), are encouraged to contact the firm before October 14, 2025.

globenewswire.com

The Gross Law Firm Reminds Unicycive Therapeutics, Inc. Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of October 14, 2025 – UNCY

NEW YORK, Oct. 13, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY).

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