FDA Action Alert: Argenx, Aldeyra, Intercept and Sarepta

The FDA is set to make four important decisions this week, including the approval of Argenx’s subcutaneous efgartigimod for adults with generalized myasthenia gravis, Aldeyra’s investigational intravitreal injection ADX-2191 for primary vitreoretinal lymphoma, Intercept Pharmaceuticals’ obeticholic acid for pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis, and Sarepta’s gene therapy candidate SRP-9001 for Duchenne muscular dystrophy. These decisions are highly anticipated by patients and industry alike.

This week, the FDA will make four crucial decisions that include approving a subcutaneous version of Argenx's efgartigimod for adults with generalized myasthenia gravis (gMG), an intravitreal injection called ADX-2191 for primary vitreoretinal lymphoma developed by Aldeyra, obeticholic acid from Intercept Pharmaceuticals as treatment for pre-cirrhotic liver fibrosis caused by non-alcoholic steatohepatitis, and Sarepta's gene therapy candidate SRP-9001 which could be the first gene therapy