Atossa <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Receives Positive FDA Feedback, Advances Towards IND Submission for <a href="https://laohu8.com/S/Z">$(Z)$</a>-Endoxifen in Metastatic Breast Cancer
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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Atossa Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF39600) on July 29, 2025, and is solely responsible for the information contained therein.
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