$UNCY

Unicycive Therapeutics (Nasdaq: UNCY) resubmitted its NDA for oxylanthanum carbonate, an oral phosphate binder for CKD patients on dialysis. The resubmission includes new CMC data from a different vendor. The company expects FDA acceptance within 30 days and a PDUFA date 6 months from resubmission. Unicycive has $61.4M in cash, supporting operations into 2H 2027.

Unicycive Therapeutics, Inc. (UNCY) filed an SEC Form 8-K — Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers. Exhibit 99.1 Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate - Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor - The resubmission package includes 12 month

Unicycive Therapeutics (UNCY) disclosed a securities class action lawsuit filed on September 3, 2026, in the Northern District of California. The lawsuit alleges violations of federal securities laws related to public statements about its oxylanthanum carbonate phosphate binder for treating hyperphosphatemia. The company states it believes the claims are meritless and plans to defend itself vigorously.

Unicycive Therapeutics, Inc. (UNCY) filed an SEC Form 8-K — Other Events. Item 8.01 Other Events . On September 3, 2026, a securities class action lawsuit was filed in United States District Court for the Northern District of California against Unicycive Therapeutics, Inc. (the “Company”) and certain of its officers. This action alleges violations of t

Unicycive Therapeutics, Inc. disclosed in an amended Schedule 13G that Vivo Opportunity Fund Holdings, L.P. and Vivo Opportunity, LLC report beneficial ownership of 4,856,259 shares, or 9.99%, based on 27,855,257 shares outstanding as of Aug. 12, 2026. The stake includes 550,000 common shares plus conversion of Series A-3/A-4/A-5 preferred underlying warrants exercisable within 60 days.

Unicycive Therapeutics (NASDAQ:UNCY) shares rose about 2% premarket after it reported a Q2 loss of $0.06 per share versus a $0.48 consensus. Net loss was $1.7M, down from $6.5M, helped by $8.0M other income from warrant liability fair value changes. The FDA issued a Complete Response Letter for OLC, citing third-party manufacturing deficiencies; an inspection is scheduled and the company plans to resubmit. Cash: $61.4M, runway into 2027.

Unicycive Therapeutics, Inc. (UNCY) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update - Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing ven

Biotech news roundup: Novartis (NVS) won EU approval for Itvisma for SMA; HUTCHMED (HCM) got China approval for ORPATHYS (savolitinib) in MET-amplified gastric cancer; Vertex (VRTX) expanded CASGEVY to children as young as 2; Unicycive (UNCY) received an FDA CRL for its CKD dialysis NDA; Ipsen (IPN.PA) agreed to buy Memo Therapeutics (~€700m) and Kartos ($450m).

Unicycive Therapeutics, Inc. (UNCY) filed an SEC Form 8-K — Submission of Matters to a Vote of Security Holders. false 0001766140 0001766140 2026-06-19 2026-06-19 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report

Unicycive Therapeutics, Inc. (UNCY) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. false 0001766140 0001766140 2026-06-05 2026-06-05 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Repor