原始来源记录
重大申请已提交
Aquestive 将于 2026 年第三季度重新提交 Anaphylm NDA
Aquestive 已完成人体因素验证和药代动力学研究，以应对 FDA 于 2026 年 1 月 30 日发出的 CRL。该公司计划在 2026 年第三季度重新提交 Anaphylm NDA，并将申请加速审评；CRL 中未提及任何 CMC 缺陷。
关键事实
- 申报时间
- 2026年8月11日 20:06
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 q22026-ex991earningsrelease.htm EX-99.1 Document Exhibit 99.1 Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update • Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film • Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026 • Continues pre-launch medical affairs activities and payer engagement • On track to begin ex-U.S. filings of Anaphylm in Q4 2026 • Company to host investor call on August 12, 2026, at 8:00 a.m. ET Warren, N.J., August 1 1, 2026 – Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative scienc