Unicycive Shares Plummet as FDA Flags Kidney Disease Drug Application Issues

Unicycive Therapeutics shares fell 31% after the FDA flagged issues related to a manufacturing vendor for its proposed kidney-disease drug, oxylanthanum carbonate. The company is working with partners to resolve the concerns and expects a final decision by June 28. Unicycive has responded to all FDA information requests and is seeking approval for the drug to treat hyperphosphatemia in chronic kidney disease patients on dialysis.

Unicycive Therapeutics (UNCY) saw its shares plummet 31% premarket after the U.S. Food and Drug Administration (FDA) flagged manufacturing issues related to its proposed kidney-disease drug, oxylanthanum carbonate (OLC). The company stated that the FDA has identified deficiencies at a third-party manufacturing vendor, which precludes any label discussions between the FDA and Unicycive [2].

Unicycive, which is seeking FDA approval of OLC for hyperphosphatemia in chronic kidney disease patients on dialysis, has responded to all FDA information requests and anticipates a final decision by the Prescription Drug User Fee Act (PDUFA) action date of June 28 [3]. The company is working with its partners to resolve the FDA's concerns, which involve a third-party subcontractor of its Contract Development and Manufacturing Organization (CDMO), not its drug substance vendor [3].

Despite the setback, Unicycive remains confident in the potential of OLC, which leverages proprietary nanoparticle technology to bind phosphate and reduce the pill burden for patients. The drug is supported by data from three clinical studies and multiple preclinical studies, along with chemistry, manufacturing, and controls (CMC) data [3]. OLC is protected by a strong global patent portfolio, with issued patents on composition of matter lasting until 2031, and the potential for patent term extension until 2035 [3].

Unicycive's portfolio also includes UNI-494, aimed at treating acute kidney injury-related conditions, which has completed a Phase 1 dose-ranging safety study and received orphan drug designation for the prevention of Delayed Graft Function in kidney transplant patients [3]. The company's financial position is strong, with a cash balance of $19.8 million at the end of the quarter, supporting operations until its next development milestone [3].

Analysts have maintained positive ratings on Unicycive, with Lucid Capital Markets initiating coverage with a Buy rating, citing the potential launch of OLC as a key factor. Benchmark analysts maintained a Speculative Buy rating and a $3.00 price target, with a focus on the anticipated FDA approval for OLC [3]. Despite the recent setback, the stock has shown resilience, delivering an impressive 18% return over the past week and maintaining strong momentum with a 41% gain over the past year [3].

References:
[1] https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3SD0NU:0-unicycive-tumbles-as-fda-flags-manufacturing-issues-with-kidney-disease-drug/
[2] https://www.marketwatch.com/story/unicycive-shares-slide-as-fda-flags-issues-related-to-kidney-drug-application-c76aa479
[3] https://ng.investing.com/news/company-news/fda-flags-issues-at-drug-manufacturer-for-unicycives-kidney-therapy-93CH-1960170