Atossa Therapeutics Receives FDA Orphan Drug Designation for (Z)-endoxifen

As previously reported, Craig-Hallum initiated coverage of Atossa Therapeutics with a Buy rating and $4 price target. The firm points out that Z-endoxifen is a novel and potent SERM that can treat all stages of breast cancer. As the primary therapeutic metabolite of tamoxifen, Z-endoxifen is de-risked and has demonstrated differentiated efficacy and an advantageous safety profile in multiple clinical studies, Craig-Hallum argues, adding that Z-endoxifen development is focused on metastatic breast cancer, which offers the fastest path to market and can strategically support future expansion to early disease settings. The most notable opportunity is prevention, where Z-endoxifen's ability to avoid menopausal-like side effects can support uptake in a large TAM of over 10M women at high-risk of developing breast cancer in the U.S. The firm believes Atossa is undervalued and sees opportunity for share appreciation as Z-endoxifen gains further validation with readouts from neoadjuvant studies expected next year and design details for a Phase III metastatic breast cancer study and initiation expected by year-end 2025.