11:01 AM EDT, 03/20/2024 (MT Newswires) -- Celularity ( CELU ) said Wednesday it submitted an application to the US Food and Drug Administration requesting an orphan drug designation for PDA-002 as a treatment for genetic muscle disorder facioscapulohumeral muscular dystrophy.

The FDA has already approved the investigative new drug application for PDA-002 and Celularity ( CELU ) will start a phase 1/2 study in H2, according to the company.

The FDA gives the orphan drug label to new drugs for the treatment of diseases that affect fewer than 200,000 people in the US, Celularity ( CELU ) added.

The company shares were down 5.9% in recent trading.

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