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Atossa Wins FDA Clearance to Advance (Z)-Endoxifen Trial

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Atossa Wins FDA Clearance to Advance (Z)-Endoxifen Trial

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Atossa Therapeutics ( (ATOS) ) has issued an update.

On January 6, 2026, Atossa Therapeutics announced that the U.S. Food and Drug Administration issued a “Study May Proceed” letter for the company’s investigational new drug application to study its lead candidate (Z)-Endoxifen in metastatic ER+/HER2- breast cancer. The regulatory clearance marks a key milestone that allows Atossa to advance clinical investigation of (Z)-Endoxifen, which has shown a favorable safety profile and distinct pharmacology from tamoxifen, and may offer a treatment option for tumors resistant to other endocrine therapies, potentially strengthening the company’s position in the oncology pipeline and enhancing the strategic value of its intellectual property around (Z)-Endoxifen.

The most recent analyst rating on (ATOS) stock is a Hold with a $0.64 price target. To see the full list of analyst forecasts on Atossa Therapeutics stock, see the ATOS Stock Forecast page.

Spark’s Take on ATOS Stock

According to Spark, TipRanks’ AI Analyst, ATOS is a Neutral.

The score is primarily held down by weak financial performance (no revenue, ongoing losses, and worsening cash burn) and bearish technicals (below major moving averages with negative MACD). Positive corporate developments (FDA regulatory strategy progress and a new CFO) provide some support, but valuation signals are limited by negative earnings and no dividend.

To see Spark’s full report on ATOS stock, click here.

More about Atossa Therapeutics

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company focused on developing innovative medicines in oncology and other areas of significant unmet medical need. Its lead product candidate is (Z)-Endoxifen, a proprietary oral Selective Estrogen Receptor Modulator/Degrader being developed for multiple clinical settings, supported by a growing global intellectual property portfolio including recently issued U.S. patents and pending applications worldwide.

Average Trading Volume: 1,086,809

Technical Sentiment Signal: Sell

Current Market Cap: $79.72M

See more insights into ATOS stock on TipRanks’ Stock Analysis page.

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