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Atossa Completes FDA Meeting on Regulatory Strategies

Story Highlights
  • Atossa Therapeutics held a Type C meeting with the FDA to discuss (Z)-endoxifen strategies.
  • The meeting is expected to accelerate Atossa’s clinical development and regulatory review processes.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Atossa Completes FDA Meeting on Regulatory Strategies

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Atossa Therapeutics ( (ATOS) ) has shared an announcement.

On December 4, 2025, Atossa Therapeutics announced the completion of a Type C meeting with the FDA on November 17, 2025, to discuss regulatory strategies for advancing (Z)-endoxifen. The FDA provided feedback on potential expedited pathways for metastatic, neoadjuvant, and risk-reduction breast cancer settings, which Atossa believes will help accelerate its clinical development and regulatory review processes. This meeting marks a significant milestone for Atossa’s programs, as it aims to shorten regulatory timelines and enhance its development strategy across multiple breast cancer indications.

The most recent analyst rating on (ATOS) stock is a Buy with a $7.00 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 Underperform.

Atossa Therapeutics’ stock score is weighed down by significant financial challenges, including ongoing operational losses and negative cash flow, despite a debt-free balance sheet. Technical indicators suggest short-term overbought conditions, while the valuation remains unattractive due to a lack of profitability and dividends. Although the earnings call provided some positive guidance on cost reductions and clinical progress, these are overshadowed by the company’s financial instability.

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

More about Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies in oncology, particularly for breast cancer treatment and prevention. The company is advancing its proprietary formulation of (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator/Degrader, across various breast cancer indications.

Average Trading Volume: 861,480

Technical Sentiment Signal: Strong Sell

Current Market Cap: $90.43M

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

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