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Atossa Therapeutics Details Accelerated FDA Strategy to Advance (Z)-Endoxifen Across Breast Cancer Continuum
Company positioned to pursue expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settingsSEATTLE, Dec. 4, 2025 /PRNewswire/ -- Atossa
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"Company positioned to pursue expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settingsSEATTLE, Dec. 4, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (\"Atossa\" or the \"Company\"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, announced the completion of a Type C meeting with the U.S. Food and Drug Administration (\"FDA\") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. During the meeting, the FDA provided the Company feedback on potential expedited regulatory pathways and development options across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.\n \n \n \n \n \n \n \nThe meeting focused on clinical development design, endpoint strategy, and pathways that could support a streamlined registrational approach. Atossa believes the FDA interaction meaningfully clarified potential routes to accelerate clinical development and regulatory review for (Z)-endoxifen, helping to position the Company to pursue a faster and more focused development strategy across multiple breast cancer indications.\"This meeting was a meaningful development milestone for our programs,\" said Steven Quay, M.D., Ph.D., Atossa's President and Chief Executive Officer. \"We used this discussion to incorporate FDA feedback into our development planning that could meaningfully shorten our regulatory timeline. We continue to aggressively execute the advancement of (Z)-endoxifen across the breast cancer continuum and toward potential registration pathways.\"This includes multiple high-value clinical settings, including:Metastatic breast cancer (mBC): A dose-ranging study is in preparation as part of the Company's strategy to support registrational development.Neoadjuvant ER+/HER2- breast cancer: Enrollment and data generation continue in the Phase 2 EVANGELINE trial.Breast cancer risk-reduction: Development includes a low-dose strategy targeting mammographic breast density and overall breast cancer risk.In support of its metastatic breast cancer program, Atossa recently submitted an Investigational New Drug application (\"IND\") to the FDA and is awaiting feedback. The Company also anticipates additional IND submissions in 2026 to advance combination strategies and explore opportunities beyond...