FibroGen: Pamrevlumab Gets FDA's Fast Track Designation To Treat Duchenne Muscular Dystrophy

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Biotech company FibroGen Inc. (FGEN) announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation for the company's anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy or DMD.

In pre-market activity on Nasdaq, FibroGen shares were gaining around 4 percent to trade at $19.30.

The company said the latest FDA designation follows review of the Phase 2 clinical data from a single-arm trial in non-ambulatory patients with DMD. It represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.

Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor, an important biological mediator in fibrotic and proliferative disorders.

Pamrevlumab is currently being evaluated in two Phase 3 trials for the treatment of DMD.

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