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LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company with a market capitalization of $59.29 million, has regained compliance with Nasdaq’s minimum share price requirement, the company announced Tuesday.
The Nasdaq Stock Market’s Listing Qualifications Department confirmed that as of July 3, Unicycive’s common stock maintained an average closing share price of at least $1.00 following the company’s 1:10 reverse stock split that became effective on June 20. This resolves the previous non-compliance with Nasdaq Rule 5550(a)(2), which requires listed companies to maintain a minimum bid price. According to InvestingPro data, the stock has shown significant volatility, with a beta of 1.89, indicating higher market sensitivity than average.
Nasdaq now considers the matter closed, according to the company’s statement based on a press release.
Unicycive, which focuses on developing therapies for patients with kidney disease, has two investigational treatments in its pipeline. Its lead product, oxylanthanum carbonate, is currently under review by the U.S. Food and Drug Administration for treating hyperphosphatemia in chronic kidney disease patients on dialysis. InvestingPro analysis reveals the company maintains a healthy current ratio of 1.64 and holds more cash than debt on its balance sheet, though it is currently burning through cash rapidly. Get access to 8 more exclusive InvestingPro Tips about UNCY’s financial health and future prospects.
The company’s second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients. This treatment has completed a Phase 1 dose-ranging safety study in healthy volunteers. Two analysts have recently revised their earnings expectations upward for the upcoming period, though the company is not expected to be profitable this year.
The compliance announcement was disclosed in Unicycive’s Current Report on Form 8-K filed on July 8.
In other recent news, Unicycive Therapeutics Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration concerning its New Drug Application for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL highlighted deficiencies at a third-party manufacturing vendor, unrelated to the drug itself, and did not raise concerns about the pre-clinical, clinical, or safety data. Unicycive is taking steps to address these issues by identifying a second manufacturing vendor and plans to request a Type A meeting with the FDA to discuss next steps. The company reports an unaudited cash balance of approximately $20.7 million, which is expected to sustain operations into the second half of 2026. Additionally, Unicycive announced a 1-for-10 reverse stock split, effective June 18, 2025, to regain compliance with Nasdaq’s listing requirements. This move will reduce outstanding shares from about 126.4 million to 12.6 million. Meanwhile, H.C. Wainwright analysts have reiterated a Buy rating on Unicycive stock, maintaining a $9.00 price target despite the manufacturing compliance issue. The analysts expressed confidence in the company’s core thesis and are not adjusting their financial model at this time.
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