Unicycive: Itinakda ng FDA ang petsa ng PDUFA na Hunyo 29, 2026 para sa muling pagsusumite ng OLC NDA

Tinanggap ng FDA ang muling pagsusumite ng NDA para sa oxylanthanum carbonate (OLC) at itinakda ang target na petsa ng aksyon ng PDUFA sa Hunyo 29, 2026. Ang pagsusuri ay nananatiling nasa tamang landas nang walang alalahanin na ibinangon tungkol sa preclinical, clinical, o safety data. Ang kumpanya ay nagpapatuloy sa mga aktibidad ng commercial-readiness bago ang potensyal na paglulunsad.

Mahahalagang fact

Na-file: May 12, 2026, 11:51 AM
Kaganapan: Naitakda 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 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