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Investing.com - Benchmark raised its price target on Unicycive Therapeutics (NASDAQ:UNCY) to $21.00 from $3.00 on Monday, while maintaining a Speculative Buy rating on the stock. According to InvestingPro data, analyst targets for UNCY range from $30 to $105, with the stock currently trading at $3.86 after falling over 11% in the past week.
The price target adjustment reflects a 1:10 reverse split and an updated discount rate, according to Benchmark. The firm continues to believe that manufacturing issues identified in a Complete Response Letter (CRL) from the FDA are "manageable" and that the company will eventually receive approval for its Oxylanthanum Carbonate (OLC) drug. InvestingPro analysis shows the company maintains a WEAK financial health score of 1.41, with additional insights available to subscribers.
Unicycive received the CRL on June 30, 2025, related to FDA manufacturing inspection deficiencies at a third-party contractor for its CDMO. The company plans to complete a Type A meeting with the FDA to align on a strategy to resolve the remaining issues.
Benchmark noted that the inspection findings did not relate to the Unicycive drug substance itself. A backup vendor with a history of successful regulatory inspections has already produced OLC drug product, which could support resolution of the chemistry, manufacturing and controls (CMC) issues identified in the CRL.
Unicycive reports an unaudited cash balance of approximately $22.3 million, which the company states provides sufficient resources to fund operations into the second half of 2026. While the company holds more cash than debt with a current ratio of 2.18, InvestingPro data indicates rapid cash burn remains a key concern for investors.
In other recent news, Unicycive Therapeutics, Inc. disclosed that it is facing a securities class action lawsuit in the United States District Court for the Northern District of California. The lawsuit alleges violations of federal securities laws concerning public statements about its new drug application for oxylanthanum carbonate phosphate binder. Additionally, Unicycive announced it has been granted a U.S. patent for its investigational drug UNI-494, aimed at treating Chronic Kidney Disease. This marks the second patent for UNI-494, with a Phase 1 clinical study already completed in healthy volunteers.
Furthermore, Unicycive has regained compliance with Nasdaq’s minimum share price requirement following a 1:10 reverse stock split. The company also reported receiving a Complete Response Letter (CRL) from the FDA for its Oxylanthanum Carbonate treatment. The FDA identified deficiencies at a third-party manufacturing vendor, though these were unrelated to the drug itself. Unicycive plans to seek a Type A meeting with the FDA to address the issues raised in the CRL.
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