Unicycive Therapeutics, Inc. UNCY

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

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 resubmissionCurrent cash position allows runway into 2H 2027 MOUNTAIN VIEW, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Unicycive The

LOS ALTOS, Calif., Sept. 01, 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 H.C. Wainwright 28th Annual Global Investment Conference on Tuesday, September 15, 2026, at 11 a.m. ET. A link to the live and archived webcast may be accessed on the Unicycive website unde

Unicycive Therapeutics, Inc. (NASDAQ:UNCY) shares gained 2.

- Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor - FDA has assigned a facility inspection to third-party manufacturing vendor of OLC - As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027 MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clin

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In late June 2026, Unicycive Therapeutics received a Complete Response Letter from the FDA on its resubmitted oxylanthanum carbonate NDA, citing unresolved third-party manufacturing deficiencies while raising no new clinical efficacy or safety concerns and requesting no additional data. This outcome highlights how a late-stage drug’s progress can hinge on an external manufacturer’s compliance status even as labeling talks with regulators continue. We’ll now examine how the FDA’s focus on...

Unicycive Therapeutics said on Tuesday that the U.S. Food and Drug Administration has again refused to approve its drug oxylanthanum carbonate.

Healthcare stocks were lower late Tuesday afternoon, with the NYSE Healthcare Index decreasing 0.9%

Unicycive Therapeutics (UNCY) said Tuesday it has received a Complete Response Letter from the US Fo

Unicycive Therapeutics said it received a Complete Response Letter from the U.S. Food and Drug Administration due to previously identified deficiencies at a third-party manufacturing facility.

Manufacturing issues delay regulatory approvalUnicycive Therapeutics Inc. (NASDAQ:UNCY) shares fell 37% on Tuesday after the company disclosed that it had received a Complete Response Letter from the U.

-- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor -- -- FDA inspection of third-party facility did not occur during the NDA resubmission review -- -- Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label -- -- FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested -- MOUNTAIN VIEW, Cali

Unicycive Therapeutics, Inc. recently reported first-quarter 2026 results showing a net loss of US$12.82 million, reversing net income of US$570,000 a year earlier and turning prior earnings per share from continuing operations into a loss. A few days before the earnings release, the company also filed a US$7.76 million common stock shelf registration tied to an employee stock ownership plan, signaling a focus on future equity-based compensation and potential capital access. With these...