Unicycive berencana mengajukan kembali NDA OLC sebelum akhir tahun; memperkirakan PDUFA pada paruh pertama 2026

Setelah pertemuan Type A dengan FDA, Unicycive mengonfirmasi bahwa CRL terbatas pada satu masalah kepatuhan manufaktur pihak ketiga. Perusahaan kini memperkirakan akan mengajukan kembali NDA sebelum akhir tahun, yang akan memicu tanggal PDUFA baru pada paruh pertama 2026.

Fakta utama

Diajukan: 28 Okt 2025, 11.30
Peristiwa: Tanggal PDUFA diperpanjang
Arah: Netral
Perusahaan: UNCYUnicycive
Aset: oxylanthanum carbonate
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 29 Jun 2026 · Surat tanggapan lengkap

Kutipan sumber

EX-99.1 2 ea026272301ex99-1_unicycive.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED OCTOBER 28, 2025 Exhibit 99.1 Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End - Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC LOS ALTOS, California, October 28, 2025 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response

SEC 8-K