Catalyst plunges after FDA approves LEMS treatment for children
The U.S. Food and Drug Administration last night approved Ruzurgi tablets for the treatment of Lambert-Eaton myasthenic syndrome, or LEMS, in patients 6 to less than 17 years of age. "This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for use in adults," the FDA stated in its press release announcing the approval. The approved treatment for LEMS in adults is Catalyst Pharmaceuticals' Firdapse. Cantor Fitzgerald analyst Charles Duncan tells investors he does not see the approval of Jacobus' Ruzurgi having a large impact in Firdapse's market potential, as he estimates that the pediatric population consists of less than 5% of the prevalent LEMS population. However, in pre-market trading, Catalyst shares are down $2.23, or 36.5%, to $3.88.