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Atossa Gets FDA Rare Pediatric Disease Tag For (Z)-Endoxifen In McCune-Albright Syndrome

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Atossa Therapeutics, Inc. (ATOS) on Monday said the U.S. Food and Drug Administration has granted Rare Pediatric Disease designation to (Z)-endoxifen for the treatment of McCune-Albright Syndrome in females.

McCune-Albright Syndrome is a rare genetic disorder caused by mutations in the GNAS gene, leading to endocrine abnormalities.

The Rare Pediatric Disease designation is given to drug candidates targeting serious or life-threatening conditions that primarily affect individuals from birth to 18 years of age. If approved, the drug may qualify for a Priority Review Voucher, which can be used to obtain priority review for a future application or sold to another company.

Recent Priority Review Voucher sales have ranged from about $100 million to $205 million.

Atossa shares were up more than 1% in pre-market trading after closing at $5.33 on Friday.

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