FDA issues Complete Response Letter for Unicycive's oxylanthanum carbonate NDA; company plans Type A meeting

Unicycive Therapeutics, Inc.

CRL cites deficiencies at third-party manufacturing vendor unrelated to OLC drug; no clinical or safety concerns.
Second manufacturing vendor already produced OLC drug product; may resolve CMC issues identified in CRL.
Unicycive plans to immediately request a Type A meeting with FDA to align on next steps.
Preliminary unaudited cash ~$20.7M as of June 30, 2025; cash runway expected into H2 2026.

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