原始来源记录
重大申请已受理
Inhibrx：FDA受理ozekibart BLA，PDUFA日期定为2027年4月14日
FDA已受理ozekibart用于常规软骨肉瘤的BLA，并指定PDUFA目标日期为2027年4月14日。受理文件标志着该资产从临床开发进入监管审查阶段。公司还计划在2026年第四季度与FDA召开会议，讨论一线CRC及四线CRC的加速审批路径。
关键事实
- 申报时间
- 2026年8月13日 20:10
- 事件
- 申请已受理
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2027年4月14日 · 积极
来源摘录
EX-99.1 2 exhibit99106302026.htm EX-99.1 Document Exhibit 99.1 Inhibrx Reports Second Quarter 2026 Financial Results San Diego, CA, August 13, 2026 – Inhibrx Biosciences, Inc. (Nasdaq: INBX) (“Inhibrx” or the “Company”) today reported financial results for the second quarter of 2026. The biopharmaceutical company has two programs in ongoing clinical trials. Recent Corporate Highlights and Upcoming Milestones • Oxford Loan Amendment. In July 2026, the Company entered into a second amendment to the Loan and Security Agreement (Second Amendment) with Oxford Finance LLC (Oxford), which provides for an additional $325.0 million in gross proceeds, (i) $100.0 million of which was funded upon execution of the amendment and (ii) up to an additional $225.0 million which, upon the Company’s reques