Registro de fonte primária
Nível de decisãoData PDUFA definida
Aquestive: NDA da Anaphylm no caminho certo para PDUFA em 31 de janeiro de 2026
FDA confirmed no Advisory Committee meeting is required for the Anaphylm NDA. The application remains on schedule for its January 31 2026 PDUFA goal date. The company is advancing U.S. launch preparations and regulatory activities in Canada and the EU.
Fatos principais
- Arquivado
- 5 de nov. de 2025, 21:04
- Evento
- Data PDUFA definida
- Direção
- Neutro
- Empresa
AQSTAquestive- Ativo
- epinephrine
- Fonte
- SEC 8-K
- Confiança
- Com fonte
- Calendário
- Decisão da FDA (PDUFA) · 31 de jan. de 2026 · Carta de resposta completa (CRL)
Trecho da fonte
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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