Company positioned to pursue expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settingsSEATTLE, Dec. 4, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, announced the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. Durin ...

Core Insights - Atossa Therapeutics is advancing its research on (Z)-endoxifen for breast cancer treatment and prevention, with four abstracts accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) [1][2]. Presentation Details - The first poster presentation will cover initial results from the RECAST DCIS trial, focusing on active surveillance and novel endocrine therapy agents for DCIS management, scheduled for December 11, 2025 [3]. - The second presentation will discuss the use of low-dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot, also on December 11, 2025 [3]. - The third presentation will explore how (Z)-endoxifen maintains ER antagonist function against ESR1 mutants, scheduled for December 12, 2025 [3]. - The final presentation will detail a randomized Phase 2 non-inferiority trial comparing (Z)-endoxifen plus Goserelin versus Exemestane plus Goserelin as neoadjuvant treatment for premenopausal women with ER+/HER2- breast cancer, set for December 12, 2025 [3]. Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet needs in breast cancer, emphasizing disciplined capital allocation to support future regulatory submissions and potential commercialization [4].

Core Insights - Atossa Therapeutics has appointed CORE IR to enhance investor awareness and strengthen shareholder engagement [1][2] - The collaboration aims to broaden the company's reach to both institutional and retail audiences [1] - CORE IR will provide a comprehensive suite of investor relations services, including strategic messaging and investor outreach [2] Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on innovative approaches to breast cancer treatment and prevention [3] - The company's lead product candidate, (Z)-endoxifen, is designed for use across the breast cancer spectrum, including risk-reduction and treatment in various settings [3] - Atossa is committed to advancing clinical research programs to improve patient outcomes and create sustainable value for shareholders [3]