原始来源记录
决策级完整回复函 (CRL)
Unicycive 收到 oxylanthanum carbonate NDA 的 CRL
FDA 发布 CRL，引用与 2025 年 6 月 CRL 中相同的第三方生产缺陷。未提出临床疗效或安全性问题，也未要求 Unicycive 提供额外数据。公司现等待第三方生产供应商通过 FDA 检查后重新提交 NDA。
关键事实
- 申报时间
- 2026年8月12日 12:04
- 事件
- 完整回复函 (CRL)
- 方向
- 消极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年6月29日 · 完整回复函 (CRL)
来源摘录
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