ATOSSA THERAPEUTICS, INC. secures FDA rare pediatric disease status for Z-endoxifen in McCune-Albright syndrome

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Ashutosh Sureka

13.05.2026

ATOSSA THERAPEUTICS, INC. secures FDA rare pediatric disease status for Z-endoxifen in McCune-Albright syndrome — FDA grants Atossa rare disease status

ATOSSA THERAPEUTICS, INC. has been granted a Rare Pediatric Disease designation by the FDA for its (Z)-endoxifen therapy targeting McCune-Albright syndrome.

This regulatory milestone supports ongoing engagement with the FDA as the company evaluates development paths for this rare pediatric endocrine disorder. The designation provides increased support for future regulatory filings and could expedite the drug's potential pathway to approval.

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Atossa Therapeutics has recently presented endoxifen as a novel approach to Duchenne muscular dystrophy. The company also participated in LSINW2026 in Seattle to engage with industry leaders on cell therapy innovation, according to a prior update. These efforts highlight Atossa’s continued focus on advancing therapeutic programs in rare diseases and related fields.

This material may contain third-party opinions, none of the data and information on this webpage constitutes investment advice according to our Disclaimer. While we adhere to strict Editorial Integrity, this post may contain references to products from our partners.

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