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

FDA menerima pengajuan ulang NDA untuk oxylanthanum carbonate dan menetapkan tanggal target tindakan PDUFA pada 29 Juni 2026. Pengajuan ulang tersebut mengatasi masalah manufaktur dari vendor pihak ketiga dan tidak mengandung data klinis atau keamanan baru. Perusahaan melanjutkan persiapan peluncuran komersial menjelang potensi persetujuan dan peluncuran pada 3Q26.

Fakta utama

Diajukan: 30 Mar 2026, 11.29
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 ea028394201ex99-1.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED MARCH 30, 2026 Exhibit 99.1 Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update - Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 - Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26 - As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, with expected runway into 2027 LOS ALTOS, Calif., March 30, 2026 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing thera

SEC 8-K