Sanofi announced plans to pursue global regulatory submissions for amlitelimab in atopic dermatitis, citing the totality of data despite mixed Phase III results. The OX40‑ligand inhibitor met primary endpoints in at least one late‑stage study but missed statistical thresholds under European counting rules in another trial, raising regulatory uncertainty across regions. Sanofi said the program’s convenience and differentiated profile justify filing, even as safety surveillance reported a single case of a skin cancer in a Phase II safety study. Analysts note U.S. filing routes may be viable while European regulators could require additional evidence, leaving commercialization prospects region‑dependent.