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Astellas Pharma : FDA Lifts Clinical Hold On Trial Of AT845 In Late-Onset Pompe Disease

Astellas Pharma Inc. (ALPMY,ALPMY) said Friday that the U.S. Food and Drug Administration has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease or LOPD.

The company stated that it is working on completing the clinical and regulatory activities necessary to resume dosing in the FORTIS clinical trial.

According to the company, the clinical hold lift will have no impact on its financial forecasts of the current fiscal year ending March 31, 2023.

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