Unicycive: FDA tetapkan tanggal PDUFA 29 Juni 2026 untuk pengajuan ulang NDA OLC

FDA menerima pengajuan ulang NDA untuk oxylanthanum carbonate (OLC) dan menetapkan tanggal aksi target PDUFA pada 29 Juni 2026. Tinjauan tetap berjalan sesuai jadwal tanpa kekhawatiran yang muncul terkait data praklinis, klinis, atau keamanan. Perusahaan melanjutkan aktivitas kesiapan komersial menjelang peluncuran potensial.

Fakta utama

Diajukan: 12 Mei 2026, 11.51
Peristiwa: Tanggal PDUFA ditetapkan
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 ea029027701ex99-1.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED MAY 12, 2026 Exhibit 99.1 Unicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update - U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 - Commercial readiness activities continue in anticipation of the potential commercial launch of OLC MOUNTAIN VIEW, Calif., May 12, 2026 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2026, and

SEC 8-K