Outlook Therapeutics：FDA PDUFA 目标日期为 2025 年 12 月 31 日，适用于 ONS-5010

8-K 文件确认 FDA 已将 ONS-5010 BLA 在湿性 AMD 适应症的 PDUFA 目标日期定为 2025 年 12 月 31 日。这是美国潜在批准决定前针对贝伐珠单抗眼科制剂的最后监管里程碑。

关键事实

申报时间: 2025年12月19日 13:30
事件: PDUFA 日期确定
方向: 中性
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 tm2533934d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Fiscal Year 2025 ISELIN, N.J., December 19, 2025 — Outlook Therapeutics, Inc . (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for fiscal year 2025. Financial Highlights for the Fiscal Year Ended September 30, 2025 For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $62.4 million, or $1.79 per basic and diluted share, and $1.4 million of revenue. This compares with net loss attributable to common stockholders of $75.4 million, or $4.06 per basic and diluted share, and no revenue for

SEC 8-K