Registro de fuente primaria

MaterialSolicitud presentada

Aquestive volverá a presentar la NDA de Anaphylm en el tercer trimestre de 2026

Aquestive completó los estudios de validación de factores humanos y PK necesarios para responder a la CRL de la FDA del 30 de enero de 2026. La compañía planea volver a presentar la NDA de Anaphylm en el tercer trimestre de 2026 y solicitará revisión acelerada; no se citaron deficiencias de CMC en la CRL.

Datos clave

Presentado
11 ago 2026, 20:06
Evento
Solicitud presentada
Dirección
Neutral
Fuente
SEC 8-K
Confianza
Con fuente

Extracto de la fuente

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

SEC 8-K

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