Why Is Unicycive Therapeutics Stock Falling Tuesday?

Unicycive Therapeutics, Inc. (NASDAQ: UNCY ) on Monday said the U.S.

Food and Drug Administration has issued a Complete Response Letter (CRL) for its resubmitted New Drug Application (NDA) seeking approval of oxylanthanum carbonate (OLC) for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Following the announcement, the stock fell over 46%.

The company said the agency’s decision was once again tied to third-party manufacturing deficiencies rather than concerns over the drug’s efficacy or safety.

Read Also: FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval FDA Repeats Prior Manufacturing Concerns According to the company, the latest CRL stems from the same manufacturing-related deficiencies identified in the agency’s June 2025 response.

Unicycive said the FDA did not request additional clinical data and raised no issues related to the drug’s safety profile or effectiveness.

The company added that it believes the FDA has not yet completed an inspection of the third-party manufacturing facility responsible for producing OLC as part of its review of the resubmitted application.

Unicycive said it chose to resubmit the NDA after concluding that the contract manufacturer had continued making progress in addressing the FDA’s previously cited compliance issues and was prepared for inspection.

Company Cites Prior FDA Discussions The biotechnology company noted that it met with the FDA during a Type A meeting in September 2025 to discuss corrective actions related to the manufacturing vendor.

According to Unicycive, the agency did not raise new concerns during that meeting and did not indicate dissatisfaction with the manufacturer’s progress toward resolving the deficiencies.

Shalabh Gupta, the company’s chief executive officer, said Unicycive continues to believe in OLC’s clinical profile. “We remain confident in the efficacy and safety of OLC,” Gupta said.

He added that the company remains engaged with the FDA on labeling and packaging discussions and expects a successful inspection of the third-party manufacturing facility, allowing it to resubmit the NDA promptly.

Application Backed By Multiple Studies The NDA for OLC is supported by results from three clinical studies, including a Phase 1 trial in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study involving CKD patients on dialysis.

In addition to the clinical program, the application includes multiple preclinical studies and chemistry, manufacturing, and controls (CMC) data supporting the investigational therapy.

UNCY Price Action: Unicycive Therapeutics shares were down 46.17% at $4.14 at the time of publication on Tuesday, according to Pro data.

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