ATOS News & Events

Atossa Genetics trading halted, news pending

Atossa Therapeutics announced that the U.S. FDA Office of Orphan Products Development has granted Orphan Drug Designation to (Z)-endoxifen for the treatment of Duchenne muscular dystrophy.

Atossa Therapeutics' (Z)-endoxifen was granted FDA orphan designation as a treatment of Duchenne muscular dystrophy, according to a post to the agency's website.

Atossa Therapeutics announced that the U.S. FDA issued a "Study May Proceed" letter for the company's study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen. "This letter marks an important regulatory milestone for Atossa and to potentially expand the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer. We believe its activity, even in tumors that have developed resistance to other endocrine therapies and in the oncogenic signaling pathway, protein kinase C beta 1, may offer a new tool in treating this disease.," said Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics President and CEO. "We appreciate the FDA's review and look forward to advancing this clinical investigation."