Unicycive Therapeutics, Inc.
No SEC Form 4 filings for $UNCY in the last 30 days.
See all $UNCY insider activity →Unicycive Therapeutics (UNCY) announced the FDA accepted its resubmitted NDA for oxylanthanum carbonate, setting a PDUFA action date of March 25, 2027. The resubmission includes CMC data from a new manufacturer, addressing prior CRLs related to manufacturing issues.
Unicycive Therapeutics' average stock price target increased from $28.4 to $29.56 by 9 analysts, with a range of $13 to $42. This implies a 599% upside from the Oct. 6 closing price. The consensus rating remains 'Buy' with all 9 analysts recommending purchase.
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.
Over the past 7 days, AlphAI's AI scored 4 news stories mentioning UNCY (Unicycive Therapeutics, Inc.). Coverage has skewed bullish: 3 bullish, 1 neutral, and 0 bearish.
Recent UNCY coverage spans regulation, financial news and earnings.
Positive regulatory progress likely lifts the stock as approval odds improve.
Unicycive Therapeutics' average stock price target increased from $28.4 to $29.56 by 9 analysts, with a range of $13 to $42. This implies a 599% upside from the Oct. 6 closing price. The consensus rating remains 'Buy' with all 9 analysts recommending purchase.
The NDA resubmission could lift the stock if the FDA accepts the filing, but pending inspection of the original vendor adds downside risk.
Potential FDA acceptance could lift the stock, while a rejection would pressure it.
The lawsuit introduces legal risk and potential liability, likely weighing on the stock.
AlphAI scores every news story that mentions UNCY with an AI model for sentiment and relevance, and aggregates insider trades from Unicycive Therapeutics, Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
Unicycive Therapeutics (UNCY) announced the FDA accepted its resubmitted NDA for oxylanthanum carbonate, setting a PDUFA action date of March 25, 2027. The resubmission includes CMC data from a new manufacturer, addressing prior CRLs related to manufacturing issues.
1 min readUnicycive Therapeutics' average stock price target increased from $28.4 to $29.56 by 9 analysts, with a range of $13 to $42. This implies a 599% upside from the Oct. 6 closing price. The consensus rating remains 'Buy' with all 9 analysts recommending purchase.
1 min readUnicycive 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.
2 min readUnicycive 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
2 min readUnicycive 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.
2 min readUnicycive 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
1 min readUnicycive 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.
3 min readUnicycive 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.
5 min readUnicycive 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
4 min readBiotech 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).
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