Unicycive Therapeutics, INC 8-K filings

Unicycive Therapeutics announced Q2 2026 financial results, reporting $61.4 million in cash and cash equivalents, and provided a business update indicating an expected New Drug Application resubmission for oxylanthanum carbonate (OLC) pending a successful third-party manufacturing vendor inspection.

Unicycive Therapeutics, Inc. announced a preliminary cash balance of approximately $61.4 million as of June 30, 2026, in its latest Form 8-K filing.

Unicycive Therapeutics has amended its sales agreement with Guggenheim Securities to increase its at-the-market offering capacity by $50 million.

Unicycive Therapeutics reports Q1 2026 financial results, with its oxylanthanum carbonate NDA resubmission on track for a June 29, 2026 PDUFA date.

Unicycive Therapeutics, Inc. announced the resignation of director Gaurav Aggarwal from its Board of Directors effective April 6, 2026.

Unicycive narrowed its 2025 net loss, reported $54.9M in cash and securities as of March 30, 2026, and confirmed a June 29, 2026 FDA PDUFA date for OLC with potential 3Q26 launch.

Unicycive Therapeutics, Inc. amended its sales agreement to double its at-the-market equity offering capacity to $100 million.

Unicycive Therapeutics confirms OLC NDA resubmission by year-end 2025 and extends cash runway into 2027, despite increased Q3 net loss.

Unicycive Therapeutics provides an update on its FDA meeting for Oxylanthanum Carbonate (OLC) and expects to resubmit its New Drug Application (NDA) by year-end, supported by a cash runway into 2027.

Unicycive Therapeutics, Inc. has been named in a securities class action lawsuit alleging federal securities law violations related to its new drug application.

Unicycive Therapeutics, Inc. announced it sold over 3.5 million common shares, generating approximately $16.3 million in net proceeds.

Unicycive Therapeutics reports Q2 2025 financial results, highlights progress on OLC FDA resolution, and maintains cash runway into H2 2026.

Unicycive Therapeutics, a clinical-stage biotechnology company, announced it has successfully regained compliance with the Nasdaq Stock Market's minimum bid price requirement, resolving a potential delisting issue.

Unicycive Therapeutics announced that the FDA issued a Complete Response Letter for its New Drug Application for oxylanthanum carbonate (OLC) due to deficiencies at a third-party manufacturing vendor, while the company maintains an unaudited cash balance of approximately $20.7 million.

Unicycive Therapeutics, Inc. has enacted a 1-for-10 reverse stock split, effective June 18, 2025, to increase its common stock's bid price and regain compliance with Nasdaq's minimum listing requirement.

Unicycive Therapeutics announced that the FDA identified cGMP compliance deficiencies at a third-party manufacturing vendor for its oxylanthanum carbonate (OLC) New Drug Application, precluding label discussions ahead of the June 28, 2025 PDUFA action date.

Unicycive Therapeutics, Inc. announced that all proposals, including the election of four directors, ratification of its accounting firm, and a reverse stock split, were approved by stockholders at its Annual Meeting held on June 9, 2025.

Unicycive Therapeutics announced a change in the time of its 2025 Annual Meeting of Stockholders, while the date and location remain the same.

Unicycive Therapeutics reports a net income for Q1 2025, driven by a decrease in warrant liability, and progresses towards potential FDA approval of Oxylanthanum Carbonate (OLC).

Unicycive Therapeutics amends warrants and exchanges preferred stock to streamline its capital structure.

Unicycive Therapeutics reports its full year 2024 financial results, highlighting progress on its OLC drug candidate and commercialization preparations.

Unicycive Therapeutics has been granted a second 180-day extension by Nasdaq to regain compliance with the minimum $1.00 per share bid price requirement.

Unicycive Therapeutics reports its Q3 2024 financial results, highlighted by the FDA's acceptance of its New Drug Application for OLC and successful completion of the UNI-494 Phase 1 trial.

The FDA has accepted Unicycive Therapeutics' New Drug Application for Oxylanthanum Carbonate (OLC), setting a target action date for June 28, 2025.

Unicycive Therapeutics has regained compliance with Nasdaq's minimum market value requirement after a period of non-compliance.

Unicycive Therapeutics reported positive financial results for the second quarter of 2024 and provided updates on the development of their key drug candidates, including the planned NDA submission for OLC by the end of August 2024.

Unicycive Therapeutics has received notices from Nasdaq for non-compliance with minimum bid price and market value requirements, placing its listing status at risk.

Unicycive Therapeutics has received a notice from Nasdaq for failing to maintain a minimum share price of $1.00, placing it at risk of delisting.

Unicycive Therapeutics has amended its manufacturing agreement with Shilpa Medicare to secure increased production of oxylanthanum carbonate tablets in anticipation of higher demand.

Unicycive Therapeutics has increased its authorized common stock from 200 million to 400 million shares after shareholder approval.