Atossa completes FDA Type C meeting; gains clarity on accelerated (Z)-endoxifen development

ATOSSA THERAPEUTICS, INC.

FDA provided feedback on regulatory pathways for (Z)-endoxifen across metastatic, neoadjuvant, and risk-reduction settings.
Company submitted IND for metastatic breast cancer program and awaits FDA feedback.
Phase 2 EVANGELINE trial continuing in neoadjuvant ER+/HER2- breast cancer.
Nearly 800 participants in completed trials; no MTD identified up to 360 mg/day.
Additional IND submissions planned in 2026 for combination strategies beyond monotherapy and breast cancer.

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