The Food and Drug Administration’s Center for Drug Evaluation and Research, Office of New Drugs said it has accepted a letter of intent for the qualification of liver stiffness measurement by vibration-controlled transient elastography as a reasonably likely surrogate endpoint for clinical trials in adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced liver fibrosis. Shares of Altimmune (ALT), which is developing a treatment for MAS, are up 7% to $3.68 following the FDA statement.
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