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Monotherapy Phase 2 study designed with FDA input; IND expected in Q4 2025
Topline results anticipated in 2026
Positions Atossa for transition into registrational Phase 3 development
SEATTLE, Aug. 20, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, announced today it has selected PSI, a leading global contract research organization (CRO), to operationalize and manage its planned (Z)-endoxifen monotherapy dose-ranging study in women with metastatic breast cancer (mBC). The study was designed following guidance from the U.S. Food and Drug Administration (FDA) and is intended to directly inform a subsequent Phase 3 trial.
The global Phase 2, multi-center dose-ranging study is designed to evaluate (Z)-endoxifen monotherapy for safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity. Patient enrollment is expected to follow the Investigational New Drug (IND) filing in Q4 2025, with topline data anticipated in 2026.
Posted In: ATOS
