FDA issues complete response letter for Unicycive’s kidney drug

LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a small-cap biotech company with a market capitalization of $86 million, announced Monday that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for its New Drug Application for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. According to InvestingPro data, the company’s stock has shown significant volatility with a beta of 2.0, reflecting the high-risk nature of clinical-stage biotech investments.

The CRL cited deficiencies at a third-party manufacturing vendor that were unrelated to OLC itself. According to the company’s press release statement, the FDA did not raise concerns about pre-clinical, clinical, or safety data in the application. InvestingPro analysis indicates the company maintains a relatively healthy current ratio of 1.64, though its overall financial health score suggests caution is warranted. Subscribers can access 8 additional key financial metrics and insights about UNCY’s operational efficiency.

Unicycive reported it has already identified a second manufacturing vendor that has produced OLC drug product, which could help resolve the manufacturing issues identified in the FDA’s letter. The company plans to request a Type A meeting with the FDA to discuss next steps.

"We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL," said Shalabh Gupta, Chief Executive Officer of Unicycive.

The company noted that the manufacturing vendor in question was cited for deficiencies following a current Good Manufacturing Practice (cGMP) inspection. These issues were identified during the routine review process after the NDA submission.

OLC is designed to reduce the pill burden for dialysis patients who need to control phosphate levels. Hyperphosphatemia affects nearly all patients with End Stage Renal Disease, with over 450,000 individuals in the U.S. requiring medication to control their phosphate levels annually.

Unicycive reported an unaudited cash balance of approximately $20.7 million, which it expects will fund operations into the second half of 2026. While the company holds more cash than debt on its balance sheet, InvestingPro data reveals it is quickly burning through cash. Notably, analysts maintain a strong buy consensus on the stock, with price targets significantly above current levels, though they don’t expect profitability this year.

In other recent news, Unicycive Therapeutics announced the implementation of a 1-for-10 reverse stock split, effective June 18, 2025, to comply with Nasdaq’s $1.00 minimum bid price requirement. This move will reduce the company’s outstanding shares from approximately 126.4 million to about 12.6 million. In regulatory matters, the FDA identified compliance deficiencies at a third-party manufacturing vendor involved in the production of Unicycive’s investigational drug, oxylanthanum carbonate (OLC). Despite this setback, H.C. Wainwright analysts have reiterated a Buy rating on Unicycive stock, maintaining a $9.00 price target. The company is working with its partners to resolve the FDA’s concerns and still expects a decision by the PDUFA date of June 28, 2025. At the recent Annual Meeting of Stockholders, all four director nominees were elected, and the reverse stock split proposal was approved. Additionally, the appointment of Grassi & Co. CPAs as the independent registered public accounting firm was ratified. Unicycive remains confident in the potential of OLC and continues to pursue its development for treating hyperphosphatemia in chronic kidney disease patients on dialysis.

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