other material
confidence high
sentiment positive
materiality 0.70
Atossa advances (Z)-endoxifen regulatory path; Q3 op-ex $9.3M
ATOSSA THERAPEUTICS, INC.
- FDA Type C meeting set Nov 17 to discuss accelerated NDA path for (Z)-endoxifen in breast cancer risk reduction; written comments received.
- Appointed Janet R. Rea as SVP R&D and Mark Daniel as CFO to lead commercialization readiness.
- Selected PSI as CRO for planned Phase 2 mBC dose-ranging study; IND filing targeted Q4 2025, topline data in 2026.
- Q3 operating expenses $9.3M (up from $6.4M); interest income $0.6M; net loss not separately disclosed.
- New Israel patent issued; two US patents under post-grant challenges; majority of IP portfolio unaffected.