Atossa Therapeutics Inc., a clinical-stage biopharmaceutical company, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its proposed dose optimization trial for (Z)-endoxifen, aimed at treating estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. This significant milestone supports Atossa's comprehensive approach in developing this treatment. The FDA's constructive responses have affirmed key elements of the clinical development plan, allowing Atossa to move forward without the need for a virtual meeting. The company is now targeting an Investigational New Drug $(IND.AU)$ submission for the fourth quarter of 2025, as it continues to advance its innovative oncology medicines. No information about joint grant or funding from multiple organizations is mentioned.
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