Hard fall, Unicycive Therapeutics stock drops tremendously after FDA rejection letter

Unicycive Therapeutics Inc. (NASDAQ: UNCY) shares fell 37% Tuesday after the company received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted New Drug Application for oxylanthanum carbonate.

The FDA letter cited deficiencies at a third-party manufacturing vendor that were previously identified in a Complete Response Letter issued in June 2025. The agency did not conduct an inspection of the third-party facility during the resubmission review process.

The FDA did not raise concerns regarding the clinical efficacy or safety data of oxylanthanum carbonate, and no additional data was requested from Unicycive. The drug is being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.

Unicycive had resubmitted the NDA based on what it believed was continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies. The company had discussed these milestones during a Type A meeting with the FDA in September 2025.

The company said it is in active discussions with the FDA regarding label and packaging, with the latest communication received on June 29 regarding carton and container labels.