Plano ng Unicycive ang muling pagsumite ng OLC NDA sa pagtatapos ng taon; bagong PDUFA sa H1 2026

Nilalayon ng Kumpanya na muling isumite ang NDA para sa oxylanthanum carbonate sa Disyembre 31, 2025 kasunod ng Type A meeting sa FDA na tumugon sa tanging kakulangan sa pagmamanupaktura na binanggit sa June CRL. Ipinahiwatig ng FDA na walang iba pang isyu; inaasahan ang bagong petsa ng PDUFA sa unang kalahati ng 2026.

Mahahalagang fact

Na-file: Nob 12, 2025, 02:12 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Positibo
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 ea026522701ex99-1_unicycive.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED NOVEMBER 12, 2025 Exhibit 99.1 Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update - Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end - Presented new analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count (2x) compared to currently available phosphate binders - Ended Q3 with $42.7 million of cash with expected runway into 2027 LOS ALTOS, California, November 12, 2025 -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnolog

SEC 8-K