11:03 AM EDT, 06/11/2024 (MT Newswires) -- Capricor Therapeutics ( CAPR ) said Tuesday the US Food and Drug Administration has agreed to a pre-biologics license application meeting regarding the company's lead CAP-1002 treatment candidate for Duchenne muscular dystrophy.

The FDA's decision is based on its review of the company's clinical data from various trials, Capricor Chief Executive Linda Marban said. The company plans to initiate a rolling BLA submission in Q3.

Capricor said it intends to further outline the submission schedule with the agency in the coming months.

Duchenne muscular dystrophy is a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.

The company's shares were up 5.2% in recent trading.

Price: 5.69, Change: +0.28, Percent Change: +5.18