regulatory
confidence high
sentiment positive
materiality 0.65
Atossa Therapeutics receives FDA 'Study May Proceed' letter for (Z)-Endoxifen metastatic breast cancer trial
ATOSSA THERAPEUTICS, INC.
- FDA issued 'Study May Proceed' letter for Atossa's IND for (Z)-Endoxifen in metastatic ER+/HER2- breast cancer.
- Trial will evaluate (Z)-Endoxifen in tumors resistant to other endocrine therapies; targets PKCβ1 pathway.
- CEO Dr. Steven Quay calls this an important regulatory milestone to expand (Z)-Endoxifen's potential use.
- (Z)-Endoxifen is a potent SERM/D with distinct pharmacology from tamoxifen; not yet approved for any indication.
- Program backed by growing global IP portfolio including issued U.S. patents and pending applications.