Atossa Therapeutics Inc. announced on October 6, 2025 that it has amended its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early‑stage ER+/HER2‑ breast cancer. The non‑registrational amendment is designed to accelerate objective readouts and reduce projected future study costs, aligning with the company’s focus on extending its operating runway and deploying capital where it is most impactful.
The revised design incorporates short‑interval objective endpoints and a two‑stage futility rule while maintaining the same safety data collection and Data Safety Monitoring Committee oversight. Run‑in data from the study, presented at the 2024 San Antonio Breast Cancer Symposium, showed a Week‑4 Ki‑67 ≤10% rate of 86% across evaluated dose levels, compared with 41% for tamoxifen and 78% for aromatase inhibitors; however, no definitive efficacy conclusions can be drawn at this stage.
Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO, said the amendment reflects “efficiency, focus, and financial discipline.” The company will use the cost savings to extend its runway and concentrate resources on NDA‑enabling activities planned for 2026, while the safety oversight and data collection protocols remain unchanged.
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