Prime Medicine Shares Jump on FDA Clearance for Investigational New Drug Application

Dow Jones09-25 05:08

Shares of Prime Medicine jumped after the biotechnology company said the Food and Drug Administration cleared its investigational new drug application for PM647 to treat the genetic disease Alpha-1 Antitrypsin Deficiency.

Shares were up 13% to $3.47 in after-hours trading on Thursday after closing down 1.9% at $3.07. Through the close, the stock had fallen 12% this year.

The company said the FDA's clearance means it can initiate clinical studies in the U.S.

"FDA clearance of the PM647 IND is an important milestone for Prime Medicine, marking continued momentum across our liver franchise," Chief Executive Officer Allan Reine said. "PM647 has the potential to change how AATD is treated, offering a Prime Editing-based approach that moves beyond protein replacement and targets the root cause of disease."

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