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SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company with a market capitalization of $105.54 million and current stock price of $0.82, announced Tuesday it has received positive written feedback from the U.S. Food and Drug Administration regarding its proposed dose optimization trial of (Z)-endoxifen for treating estrogen receptor positive, HER2-negative metastatic breast cancer. According to InvestingPro data, analysts have set price targets ranging from $4 to $7.50 for the stock, suggesting significant upside potential if development milestones are met.
The FDA’s response affirmed key elements of Atossa’s clinical development plan, eliminating the need for a previously scheduled pre-Investigational New Drug meeting. This development puts the company on track for a potential IND submission in the fourth quarter of 2025. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 12.67, indicating ample resources to fund its clinical programs, though it’s worth noting the company is currently burning through cash as it advances its pipeline.
"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," said Dr. Steven Quay, Atossa’s CEO and Chairman.
According to the company’s statement, the FDA agreed that existing clinical and nonclinical data are sufficient to initiate the monotherapy portion of the proposed dose optimization study. The agency also supported the scientific rationale for combining (Z)-endoxifen with approved breast cancer standard-of-care therapies.
Additionally, the FDA indicated that Atossa’s existing nonclinical safety data package is adequate to proceed without additional toxicity studies and confirmed that the company’s cardiac safety assessment plan is sufficient for the monotherapy portion of the trial.
(Z)-endoxifen is a Selective Estrogen Receptor Modulator that has shown ability to inhibit estrogen receptors, with activity even in tumors that have developed resistance to other endocrine therapies.
Atossa stated it will announce plans for the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study in the coming weeks.
The clinical-stage biopharmaceutical company is currently evaluating (Z)-endoxifen in three Phase 2 trials, including studies in women with ductal carcinoma in situ and women with ER+/HER2- breast cancer.
This information is based on a press release statement from Atossa Therapeutics. Investors following this development should note that the company’s next earnings report is scheduled for August 18, 2025. For deeper insights into Atossa’s financial health and growth prospects, including additional ProTips and comprehensive analysis, check out the full research report available on InvestingPro.
In other recent news, Atossa Therapeutics has announced plans for a Phase 3 clinical study, SMART 2.0, aimed at evaluating the efficacy of (Z)-endoxifen in reducing interval breast cancer in high-risk women. This development was shared at the American Association for Cancer Research Annual Meeting. Additionally, Atossa has secured a new patent for its breast cancer treatment formulations, specifically for the enteric oral formulations of (Z)-endoxifen. The patent includes 58 claims related to the formulations’ purity and stability, further strengthening Atossa’s intellectual property portfolio.
In terms of analyst activity, Ascendiant Capital raised its price target for Atossa Genetics stock to $7.50 from $7.25, maintaining a Buy rating. This adjustment is based on a net present value analysis, reflecting the balance between the company’s risks and growth prospects. Furthermore, Craig-Hallum initiated coverage on Atossa Genetics stock with a Buy rating and a price target of $4.00. They emphasized the potential of Z-endoxifen as a key factor in their positive outlook, highlighting its efficacy and safety profile in clinical studies. These recent developments indicate a focus on advancing breast cancer treatment options and enhancing the company’s market position.
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