Atossa Therapeutics shares surged 10.3% after FDA granted Rare Pediatric Disease designation to (Z)-endoxifen for McCune-Albright Syndrome.
The RPD status makes Atossa eligible for a Priority Review Voucher, historically valued between $100 million and $205 million.
CEO Steven Quay highlighted the regulatory milestone, while SVP R&D Janet Rea noted enhanced FDA engagement opportunities.
The designation targets a serious pediatric endocrine disorder affecting young girls, expanding Atossa’s pipeline beyond oncology.