Unicycive Therapeutics, Inc. (NASDAQ:UNCY – Get Free Report) shares were down 1.3% during mid-day trading on Friday. The company traded as low as $3.71 and last traded at $3.89. 1,212,401 shares changed hands during trading, an increase of 15% from the average daily volume of 1,055,401 shares. The stock had previously closed at $3.94.
Unicycive Therapeutics News Roundup
Here are the key news stories impacting Unicycive Therapeutics this week:
- Positive Sentiment: The FDA accepted Unicycive’s resubmitted New Drug Application for oxylanthanum carbonate, a potential phosphate binder for patients with chronic kidney disease on dialysis. The resubmission includes Chemistry, Manufacturing, and Controls data from a new drug-product manufacturing vendor. The FDA assigned a March 25, 2027 PDUFA action date, providing a defined regulatory catalyst, although acceptance does not guarantee approval. FDA acceptance and PDUFA date article
- Positive Sentiment: The average analyst price target reportedly increased 12.32% to $32.54, suggesting substantial potential upside relative to recent trading levels. However, price targets can change quickly and may reflect limited analyst coverage for the clinical-stage biotechnology company. Analyst price target article
- Neutral Sentiment: Multiple law firms reminded investors of a November 2, 2026 lead-plaintiff deadline in a pending securities class action covering purchases from December 29, 2025 through June 29, 2026. The notices largely repeat the same litigation information rather than represent new operating developments. Class-action deadline notice
- Negative Sentiment: The lawsuit alleges Unicycive failed to disclose that it had not inspected or audited its third-party manufacturer’s facility for current Good Manufacturing Practice compliance before an earlier NDA resubmission. Plaintiffs claim this exposed investors to another Complete Response Letter and contributed to a reported 39.1% stock decline. The allegations have not been proven, but the litigation creates legal costs, reputational risk, and uncertainty around the company’s manufacturing readiness. Securities lawsuit allegations
Analyst Ratings Changes
Several equities analysts have recently commented on the company. Weiss Ratings reiterated a “sell (d-)” rating on shares of Unicycive Therapeutics in a research report on Friday, September 4th. Guggenheim reaffirmed a “buy” rating and set a $25.00 price target (down from $37.00) on shares of Unicycive Therapeutics in a research report on Thursday, August 13th. Zacks Research raised shares of Unicycive Therapeutics from a “strong sell” rating to a “hold” rating in a research report on Wednesday, August 19th. Benchmark reaffirmed a “speculative buy” rating and set a $15.00 target price (up from $13.00) on shares of Unicycive Therapeutics in a research note on Thursday, August 20th. Finally, Wall Street Zen upgraded shares of Unicycive Therapeutics from a “sell” rating to a “hold” rating in a research report on Saturday, August 15th. Five equities research analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has issued a Sell rating to the company’s stock. According to MarketBeat, Unicycive Therapeutics presently has a consensus rating of “Moderate Buy” and an average price target of $18.25.
Read Our Latest Research Report on Unicycive Therapeutics
Unicycive Therapeutics Stock Down 1.3%
The stock’s fifty day simple moving average is $4.72 and its 200 day simple moving average is $5.96. The firm has a market capitalization of $108.34 million, a PE ratio of -2.22 and a beta of 1.83.
Unicycive Therapeutics (NASDAQ:UNCY – Get Free Report) last released its earnings results on Wednesday, August 12th. The company reported ($0.06) earnings per share (EPS) for the quarter, topping the consensus estimate of ($0.47) by $0.41. On average, analysts predict that Unicycive Therapeutics, Inc. will post -1.16 EPS for the current year.
Institutional Investors Weigh In On Unicycive Therapeutics
Large investors have recently added to or reduced their stakes in the stock. Dimensional Fund Advisors LP bought a new stake in Unicycive Therapeutics during the 1st quarter valued at about $940,000. Seven Fleet Capital Management LP purchased a new stake in Unicycive Therapeutics during the first quarter valued at approximately $367,000. Bank of New York Mellon Corp acquired a new stake in shares of Unicycive Therapeutics in the 2nd quarter worth $248,000. Bank of America Corp DE boosted its holdings in Unicycive Therapeutics by 19,327.6% in the first quarter. Bank of America Corp DE now owns 29,530 shares of the company’s stock worth $194,000 after acquiring an additional 29,378 shares in the last quarter. Finally, Renaissance Technologies LLC purchased a new stake in Unicycive Therapeutics during the 1st quarter worth approximately $161,000. 40.42% of the stock is owned by institutional investors.
Unicycive Therapeutics Company Profile
Unicycive Therapeutics, Inc (NASDAQ: UNCY) is a clinical-stage biotechnology company focused on developing treatments for kidney disease. The company’s primary focus is hyperphosphatemia, a condition in which phosphate levels become abnormally high in patients with chronic kidney disease, particularly those receiving dialysis.
Unicycive’s lead product candidate is oxylanthanum carbonate (OLC), an orally administered phosphate binder designed to bind dietary phosphate in the gastrointestinal tract and reduce its absorption into the bloodstream.
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