Unicycive Therapeutics, Inc. (UNCY)

Philadelphia, Pennsylvania--(Newsfile Corp. - February 17, 2026) - WHAT IS HAPPENING? Grabar Law Office is investigating claims on behalf of shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY).

LOS ALTOS, Calif., Feb. 04, 2026 (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 Emerging Outlook: Biotech Summit on Wednesday, February 11, 2026, at 1:30 p.m. ET.

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.

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.

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.

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

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.

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.

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.

-   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.

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.

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

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

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

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.