Atossa Therapeutics details accelerated FDA strategy to advance (Z)-endoxifen

Atossa Therapeutics (ATOS) announced the completion of a Type C meeting with the FDA on November 17 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. 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. In support of its metastatic breast cancer program, Atossa recently submitted an 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 monotherapy and breast cancer.