Unicycive Therapeutics

UNCY

Market cap $177M

Unicycive Therapeutics, Inc. (UNCY) Presents at 25th Annual Needham Virtual Healthcare Conference Transcript

NEW YORK, April 9, 2026 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) breached their fiduciary duties to shareholders.  According to a federal securities lawsuit, Insiders at Unicycive Therapeutics caused the company to misrepresent or fail to disclose that: (i) Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, public statements were materially false and misleading at all relevant times.

LOS ALTOS, Calif., April 09, 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 present at the 25th Annual Needham Virtual Healthcare Conference on Wednesday, April 15, 2026, at 3:45 p.m. ET.

LOS ALTOS, Calif., March 30, 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 full year ended December 31, 2025, and provided a business update.

New York, New York--(Newsfile Corp. - March 6, 2026) - Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) breached their fiduciary duties to shareholders. According to a federal securities lawsuit, Insiders at Unicycive Therapeutics caused the company to misrepresent or fail to disclose that: (i) Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, public statements were materially false and misleading at all relevant times.

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.