Atossa Therapeutics reports ‘positive’ FDA feedback regarding (Z)-endoxifen

Atossa Therapeutics (ATOS) announced positive written feedback from the U.S. FDA regarding the company’s proposed dose optimization trial of (Z)-endoxifen for the treatment of estrogen receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. The FDA has provided highly constructive responses ahead of the scheduled pre-Investigational New Drug meeting, affirming key elements of Atossa’s clinical development plan, negating the need for a virtual meeting, and paving the way for a potential IND submission targeted for the fourth quarter of 2025.