Unicycive Therapeutics filings document the regulatory, financing, governance, and operating disclosures of a Nasdaq-listed clinical-stage biotechnology company focused on kidney disease therapies. Form 8-K reports furnish financial results and business updates, including disclosures related to oxylanthanum carbonate, NDA activity, manufacturing matters, and the company’s cash and capital resources.
The filing record also covers common stock registered on the Nasdaq Capital Market, emerging growth company status, at-the-market equity sales under a shelf registration statement, and board and executive-governance matters. Proxy materials document director elections, auditor ratification, stockholder voting mechanics, and annual meeting procedures, while other current reports address securities litigation risk tied to public statements about the OLC program.
Unicycive Therapeutics, Inc. director Meredith Manning received grants on October 28, 2026, of 3,350 restricted stock units and 27,000 stock options covering common stock. The restricted stock units are payable solely in common stock; 837 shares vest upon grant and 209 vest monthly over 12 months beginning November 1, 2026, subject to continued service. The options have a $3.76 exercise price, an exercise date of October 28, 2027, and an expiration date of October 28, 2036.
Unicycive Therapeutics, Inc. resubmitted its New Drug Application for investigational oxylanthanum carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The resubmission includes chemistry, manufacturing and controls data from a new third-party manufacturer, 12 months of OLC drug-product stability data and additional in-vitro bridging data recommended by the FDA in prior discussions.
The company anticipates FDA acceptance within 30 days of resubmission and expects a new PDUFA date six months from resubmission. A June 2026 Complete Response Letter cited the same manufacturing deficiencies as a June 2025 letter; the FDA raised no clinical efficacy or safety concerns and requested no additional data. As of September 29, 2026, inspection of the original manufacturer had been assigned but not conducted. If that manufacturer is inspected soon and deemed cGMP-compliant, Unicycive plans to seek FDA alignment on a shorter review timeline. Cash, cash equivalents and marketable securities were $61.4 million as of June 30, 2026, supporting runway into the second half of 2027. Separately, Meredith S. Manning was appointed an independent director effective October 1, 2026, and will serve on three board committees and chair the Nominating and Corporate Governance Committee.
Nantahala Capital Management, LLC, together with Wilmot B. Harkey and Daniel Mack, reports beneficial ownership of 2,807,830 shares of Unicycive Therapeutics, Inc. common stock as of June 30, 2026. This represents 9.99% of the outstanding shares, held through funds and separately managed accounts under Nantahala’s control.
The position includes 1,406,383 shares that may be acquired within sixty days via convertible securities. All 2,807,830 shares are reported with shared voting and dispositive power, and no sole voting or dispositive power. BLACKWELL PARTNERS LLC – SERIES A has rights to dividends or sale proceeds for more than five percent of the shares reported.
Unicycive Therapeutics, Inc. is reported to have 4,856,259 shares of its common stock beneficially owned by Vivo Opportunity Fund Holdings, L.P. and its general partner, Vivo Opportunity, LLC, under an amended Schedule 13G. This position represents 9.99% of the common stock based on 27,855,257 shares outstanding as of August 12, 2026.
The reported stake includes 550,000 outstanding common shares and an additional 4,306,259 shares issuable upon conversion of Series A-3, A-4 and A-5 Convertible Preferred Stock underlying Tranche A, B and C warrants that are exercisable within 60 days. These preferred shares include blocking provisions that prevent conversion if it would result in ownership above 9.99%, although the reported share numbers reflect full convertibility without applying this cap.
Unicycive Therapeutics, Inc. reported second quarter 2026 results and provided a regulatory update on its lead kidney disease candidate, oxylanthanum carbonate (OLC). The company expects to resubmit its New Drug Application for OLC assuming completion of a successful FDA inspection of its third-party manufacturing vendor, and states that the FDA has now assigned this facility inspection. Management describes ongoing, productive dialogue with the FDA on OLC labeling and packaging and preparation for a potential commercial launch.
As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, which the company states is expected to provide runway into 2027. For the quarter ended June 30, 2026, research and development expense was $2.8 million and general and administrative expense was $7.4 million, both higher than the prior-year period primarily due to increased non-cash stock-based compensation and commercial launch preparation. Other income was $8.4 million, largely from a change in fair value of warrant liabilities, resulting in a net loss of $1.7 million, or $0.06 per share, compared with a $6.5 million net loss, or $0.52 per share, a year earlier.
Unicycive Therapeutics, Inc. reported a larger net loss while significantly strengthening its cash position for the six months ended June 30, 2026. Net loss was $14.5 million compared with $5.9 million a year earlier, driven by higher research and development and general and administrative expenses totaling $18.6 million.
Other income included a $3.2 million gain from changes in the fair value of warrant liabilities and $0.8 million of interest income, which partially offset operating losses. Operating cash outflows were $13.8 million, while financing activities provided $34.0 million of net proceeds from sales of 5,278,767 shares under an at-the-market program.
Cash, cash equivalents and marketable securities increased to $61.4 million as of June 30, 2026, from $41.3 million at December 31, 2025, and total assets were $72.0 million. Management states it believes available resources are sufficient to fund operations for at least one year. The company also discloses ongoing shareholder litigation relating to disclosures about oxylanthanum carbonate.
BlackRock, Inc. has filed a Schedule 13G reporting a passive ownership stake in Unicycive Therapeutics, Inc. common stock. BlackRock reports beneficial ownership of 1,413,381 shares, representing 5.3% of the outstanding common stock.
BlackRock has sole voting power over 1,391,049 shares and sole dispositive power over 1,413,381 shares, with no shared voting or dispositive power. Various underlying clients have economic interests in these shares, but no single client holds more than five percent of Unicycive’s outstanding common stock.
Kenkare-Mitra Sara reported acquisition or exercise transactions in this Form 4 filing.
Unicycive Therapeutics, Inc. director Sara Kenkare-Mitra reported an equity compensation award of 47,941 Restricted Stock Units on May 14, 2026. The RSUs are payable solely in common stock; 19,976 shares vest immediately and 3,995 vest monthly over seven months from June 1, 2026, contingent on continued service.