Prnewswire·2025-12-04 13:00Core Viewpoint - Atossa Therapeutics is advancing its regulatory strategy for (Z)-endoxifen, focusing on expedited pathways for metastatic, neoadjuvant, and risk-reduction settings in breast cancer treatment [1][2]. Regulatory Strategy - The company completed a Type C meeting with the FDA on November 17, 2025, which provided feedback on potential expedited regulatory pathways and development options for (Z)-endoxifen [1][2]. - The meeting clarified routes to accelerate clinical development and regulatory review, allowing Atossa to pursue a faster development strategy across multiple breast cancer indications [2][3]. Clinical Development - Atossa has submitted an Investigational New Drug (IND) application for its metastatic breast cancer program and anticipates additional IND submissions in 2026 to explore combination strategies [4]. - The clinical program has involved nearly 800 participants across multiple trials, with a focus on creating value-creating milestones [5]. Product Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) that can inhibit and potentially degrade estrogen receptors, showing activity in tumors resistant to other therapies [5]. - The company is developing a proprietary oral formulation of (Z)-endoxifen that bypasses stomach acid, enhancing bioavailability and therapeutic integrity [6]. Intellectual Property - Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including four recently issued U.S. patents and numerous pending applications worldwide [7]. Clinical Trials and Indications - The company is preparing a dose-ranging study for metastatic breast cancer and continues enrollment in the Phase 2 EVANGELINE trial for neoadjuvant ER+/HER2- breast cancer [9]. - Development efforts also include a low-dose strategy targeting mammographic breast density and overall breast cancer risk [9].