Capricor Therapeutics (CAPR) expects its San Diego manufacturing facility for Deramiocel, a treatment for Duchenne muscular dystrophy, will meet license requirements following an early inspection by the US Food and Drug Administration.
The inspection resulted in routine observations related to quality systems and documentation, but no major changes to the facility or manufacturing process were required, the company said Wednesday in a statement.
Deramiocel's Biologics License Application remains under FDA priority review, with a target approval decision set for Aug. 31. A late-cycle meeting is planned for mid-July, and the FDA advisory committee will meet on July 30.
Capricor's shares fell 1.4% in recent trading Wednesday, paring earlier losses.
Price: 13.70, Change: -0.19, Percent Change: -1.37
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