Savara presenta la BLA para MOLBREEVI en PAP autoinmune

Savara presentó una BLA a la FDA en diciembre de 2025 para MOLBREEVI (solución para inhalación de molgramostim) para la proteinosis alveolar pulmonar autoinmune. La presentación está respaldada por resultados positivos del ensayo de fase 3 IMPALA-2 que muestran una mejora estadísticamente significativa en el DLco% en la semana 24 y 48 frente a placebo, con una tolerabilidad favorable y un 100% de transición a abierto.

Datos clave

Presentado: 9 ene 2026, 13:00
Evento: Solicitud presentada
Dirección: Neutral
Empresa: SVRASavara
Activo: molgramostim
Fuente: SEC 8-K
Confianza: Con fuente

Extracto de la fuente

EX-99.1 2 d24211dex991.htm EX-99.1 EX-99.1 Corporate Overview January 2026 Developing new therapies for rare respiratory diseases Exhibit 99.1 Safe Harbor Statement © Savara Inc. All Rights Reserved. Savara Inc. (“Savara” or the “Company”) cautions you that statements in this presentation that are not a description of historical fact are forward-looking statements which may be identified by the use of words such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements regarding the potential health benefits and risks and projected development timeline of MOLBREEVI; the timing of regulatory submissions; the potential for and impact of regulatory approval; the potential addressable patient population, mar

SEC 8-K