Capricor Therapeutics shares moved higher on Monday after the Food and Drug Administration extended its review of the biotechnology company's proposed deramiocel cell therapy for Duchenne muscular dystrophy, or DMD, to consider additional study data.

Shares of the San Diego company were recently changing hands at $7.03, up almost 12%.

Capricor said the FDA extended its target action date for a decision on the resubmitted application for deramiocel to Nov. 22 after Capricor filed 24-month open-label extension data from its pivotal Phase 3 study of the drug, along with additional robustness analyses.

Capricor said it submitted the additional information as part of ongoing discussions with the FDA after an FDA advisory panel late last month recommend against approval of the drug, adding that it asked the agency to review the existing and new data in support of a refined proposed indication focused on upper-limb function.

The FDA last July rejected Capricor's initial deramiocel application, saying it hadn't met the statutory requirement for substantial evidence of effectiveness, and the company resubmitted the application late last year with additional data from the Phase 3 study.

The FDA in March said it would again review deramiocel and set a target action date of last Saturday.