Unicycive tumanggap ng CRL para sa oxylanthanum carbonate NDA

Naglabas ang FDA ng CRL na binanggit ang parehong kakulangan sa pagmamanupaktura ng third-party na nabanggit sa nakaraang CRL noong Hunyo 2025. Walang mga alalahanin sa klinikal na bisa o kaligtasan na ibinanggit at walang karagdagang data na hiniling mula sa Unicycive. Ngayon ay naghihintay ang kumpanya ng matagumpay na inspeksyon ng FDA sa third-party manufacturing vendor bago muling isumite ang NDA.

Mahahalagang fact

Na-file: Ago 12, 2026, 12:04 PM
Kaganapan: Complete response letter
Direksyon: Negatibo
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 ea030169901ex99-1.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED AUGUST 12, 2026 Exhibit 99.1 Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update - Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor - FDA has assigned a facility inspection to third-party manufacturing vendor of OLC - As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027 MOUNTAIN VIEW, Calif., August 12, 2026 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today an

SEC 8-K