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Investing.com -- Atossa Therapeutics Inc (NASDAQ:ATOS) stock surged 11.4% premarket following positive feedback from the U.S. Food and Drug Administration (FDA) regarding the company’s proposed dose optimization trial for (Z)-endoxifen.
The FDA’s written responses affirmed key elements of Atossa’s clinical development plan for treating estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer. The regulatory feedback was constructive enough to negate the need for a scheduled pre-Investigational New Drug (IND) meeting, potentially accelerating the company’s timeline toward an IND submission targeted for the fourth quarter of 2025.
"These FDA responses mark a significant milestone for the Company and are supportive of our comprehensive approach to developing (Z)-endoxifen for metastatic breast cancer," stated Dr. Steven Quay, Atossa’s Chief Executive Officer and Chairman of the Board.
The FDA agreed that Atossa’s existing clinical and nonclinical data are sufficient to initiate the monotherapy portion of the proposed dose optimization study. Regulators also supported the scientific rationale for combining (Z)-endoxifen with approved breast cancer standard-of-care therapies, including some CDK4/6 inhibitors, PI3K inhibitors, mTOR inhibitors, and capecitabine.
Additionally, the FDA indicated that Atossa’s existing nonclinical safety data package is adequate to proceed without additional general toxicity or neurotoxicity studies. The agency also confirmed that the company’s cardiac safety assessment plan for the monotherapy portion of the trial is sufficient.
Atossa plans to announce details about the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study in the coming weeks. The study design aligns with the FDA’s Project Optimus initiative, which emphasizes data-driven dose exploration to maximize benefit while minimizing toxicity.
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