Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger

The Barth Syndrome candidate application will be reviewed by the FDA, but Stealth BioTherapeutics' CEO tells the Pink Sheet that the company still does not have clear guidance on how or whether it should gather additional clinical data.

conference room table
Elamipretide's NDA filing provides a seat at the table, but Stealth BioTherapeutics still has work to do, its CEO said. • Source: Shutterstock

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