Prnewswire·2026-01-06 13:15Core Insights - Atossa Therapeutics has received a "Study May Proceed" letter from the FDA for its clinical study of (Z)-endoxifen in metastatic breast cancer, marking a significant regulatory milestone for the company [1][2] Group 1: Product Development - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms, currently under evaluation for oncology and rare diseases [3] - The proprietary oral formulation of (Z)-endoxifen has shown a favorable safety profile and distinct pharmacology compared to tamoxifen, including ER-targeted effects and PKC inhibition [3] - The (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide [4] Group 2: Company Overview - Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative medicines in oncology and other areas of significant unmet medical need [5] - The company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings [5]