Atossa recibe carta de la FDA de “Study May Proceed” para (Z)-endoxifen en cáncer de mama metastásico

La FDA autorizó la solicitud IND para (Z)-endoxifen en cáncer de mama metastásico ER+/HER2-, permitiendo a la compañía iniciar el estudio clínico planificado. Esta aprobación regulatoria avanza el programa a la siguiente etapa de desarrollo clínico.

Datos clave

Presentado: 6 ene 2026, 13:30
Evento: Otro
Dirección: Positivo
Empresa: ATOSAtossa Therapeutics
Activo: (Z)-endoxifen
Fuente: SEC 8-K
Confianza: Con fuente

Extracto de la fuente

EX-99.1 2 atos-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Atossa Therapeutics Receives FDA “Study May Proceed” Letter for (Z)-Endoxifen Investigational New Drug Application for Metastatic Breast Cancer SEATTLE, WA, January 6, 2026 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines for unmet medical needs, today announced that the U.S. Food and Drug Administration (“FDA”) issued a “Study May Proceed” letter for the Company’s study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen. “This letter marks an important regulatory milestone for Atossa and to potentially expand the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer. We beli

SEC 8-K