Plano ng Unicycive na muling isumite ang OLC NDA bago matapos ang taon; inaasahan ang PDUFA sa H1 2026

Kasunod ng Type A FDA meeting, kinumpirma ng Unicycive na ang CRL ay limitado lamang sa isang third-party manufacturing compliance issue. Inaasahan na ngayon ng kumpanya na muling isumite ang NDA bago matapos ang taon, na magdudulot ng bagong PDUFA date sa unang kalahati ng 2026.

Mahahalagang fact

Na-file: Okt 28, 2025, 11:30 AM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: UNCYUnicycive
Asset: oxylanthanum carbonate
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Hun 29, 2026 · Complete response letter

Sipi mula sa source

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