Record mula sa primary source
MateryalNaisumite ang aplikasyon
Aquestive muling isusumite ang Anaphylm NDA sa Q3 2026
Nakatapos na ang Aquestive sa human factors validation at PK studies na kinakailangan upang tugunan ang CRL ng FDA noong Enero 30, 2026. Plano ng kumpanya na muling isumite ang Anaphylm NDA sa Q3 2026 at hihingi ng expedited review; walang CMC deficiencies na binanggit sa CRL.
Mahahalagang fact
- Na-file
- Ago 11, 2026, 08:06 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Neutral
- Kumpanya
AQSTAquestive- Asset
- epinephrine
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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
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