other material
confidence high
sentiment positive
materiality 0.75
Atossa to pursue metastatic breast cancer indication; (Z)-endoxifen more than doubled PFS vs tamoxifen (7.2 vs 2.4 mo)
ATOSSA THERAPEUTICS, INC.
- Strategic decision to pursue metastatic breast cancer indication for (Z)-endoxifen, citing potentially faster regulatory path.
- Median PFS more than doubled to 7.2 months vs 2.4 months for tamoxifen in CDK4/6i-naïve patients.
- Also engaging FDA on additional indications: breast cancer prevention and neoadjuvant therapy.
- Early data show Ki-67 ≤10% response rate above 85% across doses in neoadjuvant setting.