Atossa seeks FDA meeting to accelerate breast cancer drug development

SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), currently trading at $0.79 with a market capitalization of approximately $102 million, has requested a Type C meeting with the U.S. Food and Drug Administration to discuss strategies for accelerating the development of low-dose (Z)-endoxifen for breast cancer risk reduction, the company announced Monday.

The clinical-stage biopharmaceutical company expects to update shareholders on the outcome of the meeting before the end of 2025. A favorable outcome could potentially shorten approval timelines and reduce clinical trial costs, according to the company.

The meeting request follows a review of Atossa’s (Z)-endoxifen data by regulatory affairs experts who evaluated whether existing evidence could support a faster regulatory path in various breast cancer risk-reduction settings.

"This new regulatory strategy could dramatically accelerate the timeline for the development and potential approval of low-dose (Z)-endoxifen in the reduction of the incidence of breast cancer," said Dr. Steven Quay, Chairman and CEO of Atossa.

(Z)-endoxifen is a Selective Estrogen Receptor Modulator/Degrader that has demonstrated the ability to inhibit and degrade estrogen receptors. The company is developing a proprietary enteric oral formulation that bypasses stomach acid to maintain the active form of the drug.

Atossa is currently evaluating (Z)-endoxifen in three Phase 2 studies, including trials in ductal carcinoma in situ and ER+/HER2- breast cancer.

The company reported approximately $57.9 million in cash and no debt as of June 30, 2025. According to InvestingPro analysis, Atossa maintains a strong liquidity position with a current ratio of 9.17, though the company is quickly burning through its cash reserves. For deeper insights into Atossa’s financial health and 5+ additional ProTips, explore InvestingPro’s comprehensive analysis.

This article is based on a press release statement from Atossa Therapeutics. Analyst price targets for ATOS range from $4 to $7.50, suggesting significant potential upside from current levels. Get access to detailed valuation metrics and expert analysis with InvestingPro’s exclusive research report, part of their coverage of 1,400+ US stocks.

In other recent news, Atossa Therapeutics has announced receiving positive feedback from the U.S. Food and Drug Administration (FDA) concerning its proposed dose optimization trial for (Z)-endoxifen. This trial is aimed at treating estrogen receptor positive, HER2-negative metastatic breast cancer. The FDA’s written responses have affirmed key elements of Atossa’s clinical development plan, which has allowed the company to bypass a previously scheduled pre-Investigational New Drug (IND) meeting. This advancement potentially accelerates Atossa’s timeline toward an IND submission, now targeted for the fourth quarter of 2025. These developments mark significant progress in Atossa’s clinical efforts. The constructive regulatory feedback has been a key factor in this advancement.

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