Unicycive Therapeutics

Trial and FDA signals

• FDA complete response letter Received an FDA complete response letter (NDA 218607, letter dated Jun 29, 2026). FDA NDA 218607 (Jun 29, 2026)
  Evidence (1 event)

  • Jun 29, 2026 · FDA NDA 218607
    CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Unicycive Therapeutics Inc. Attention: Shalabh Gupta, MD, MPA President & CEO Mountain View, CA (street omitted) Dear Dr. Gupta: Please refer to your new drug

Job counts as of Oct 18, 2026. All trial and FDA signals