Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Aquestive: nasa tamang landas ang NDA ng Anaphylm para sa PDUFA sa Enero 31, 2026
Kinumpirma ng FDA na hindi kailangan ng Advisory Committee meeting para sa Anaphylm NDA. Nananatili sa iskedyul ang aplikasyon para sa January 31 2026 PDUFA goal date. Isinusulong ng kumpanya ang mga paghahanda para sa U.S. launch at mga aktibidad na pang-regulasyon sa Canada at EU.
Mahahalagang fact
- Na-file
- Nob 5, 2025, 09:04 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
AQSTAquestive- Asset
- epinephrine
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Ene 31, 2026 · Complete response letter
Sipi mula sa source
EX-99.1 2 q32025-ex991earningsrelease.htm EX-99.1 Document Exhibit 99.1 Aquestive Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update • Planned U.S. launch of Anaphylm™ in the first quarter of 2026, if approved by the FDA • Advanced Anaphylm regulatory activities in Canada and the EU • Added clinical leadership to drive long-term success • Strengthened balance sheet to support planned commercial launch execution of Anaphylm • Company to host investor call on November 6, 2025, at 8:00am ET Warren, N.J., November 5, 2025 – Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today a
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