Atossa Therapeutics Announces Support of Final Rule from FDA Requiring Patient Notification of Breast Density, a Critical Step in Addressing a Known Risk Factor for Breast Cancer

Core Viewpoint - Atossa Therapeutics supports the FDA's final rule to update mammography regulations, which aims to improve breast cancer detection by requiring facilities to inform patients about breast density in understandable terms [1][2][3] Group 1: Regulatory Impact - The FDA's final rule is a significant advancement in breast cancer detection and patient outcomes, as breast density is an independent risk factor for developing breast cancer [2] - The regulation is expected to enhance early breast cancer detection by notifying women with dense breast tissue, allowing for informed discussions about supplemental screening options like ultrasound or MRI [2] Group 2: Company Initiatives - Atossa is evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials, including the Karisma-Endoxifen study, which aims to reduce mammographic breast density in premenopausal women [3][6] - The company is supporting the SMART study, a phase 2 trial to validate an AI-driven breast cancer risk assessment model, which could lead to a future phase 3 trial for (Z)-endoxifen in breast cancer prevention [4] Group 3: Product Development - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that shows efficacy in patients resistant to other hormonal treatments and targets oncogenic proteins [5] - Atossa is developing an oral formulation of (Z)-endoxifen that bypasses liver metabolism and stomach acidity, showing good tolerance in early studies [6] Group 4: Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative medicines for significant unmet medical needs in oncology, particularly in breast cancer [7]