Outlook Therapeutics 赢得 FDR 上诉；计划 2026 年 6 月重新提交 BLA

FDA 新药办公室推翻了 2025 年 12 月的 CRL，裁定 NORSE TWO 及确证性数据为 LYTENAVA 治疗 nAMD 提供了充分的有效性证据。公司将于 2026 年 6 月提交 I 类重新申请，启动 60 天 PDUFA 时钟。

关键事实

申报时间: 2026年5月26日 11:15
事件: 完整回复函 (CRL)
方向: 积极
公司: OTLKOutlook Therapeutics, Inc.
资产: bevacizumab-vikg
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年7月29日 · 完整回复函 (CRL)

来源摘录

EX-99.1 2 tm2615583d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Company plans to resubmit BLA to the FDA in June 2026 ISELIN, N.J., May 26, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted the appeal following completion of the Formal Dispute Resolution (FDR) process with the Office of New Drugs (OND). The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of neovasc

SEC 8-K