Cantor reiterates Overweight on Catalyst Pharmaceuticals after FDA lawsuit
Cantor Fitzgerald analyst Charles Duncan reiterates an Overweight rating on Catalyst Pharmaceuticals with a $10 price target after the company filed a lawsuit against the FDA challenging the recent approval of Jacobus' Ruzurgi. The approval of Ruzurgi appears to ignore the reasoning behind the Orphan Drug Act and its potential to drive innovation for future therapies, Duncan tells investors in a research note. Ruzurgi is, on the surface, priced lower than Catalyst's Firdapse, at $175,000 per year versus $375,000 per year, the analyst points out. However, if only used for the pediatric indication, Ruzurgi would be unlikely to significantly infringe on Firdapse's market share, says Duncan, who estimates the pediatric population consists of less than 5 % of the prevalent Lambert-Eaton myasthenic sydrome population. The potential concern stems from Jacobus' marketing the drug for off-label use and physicians prescribing the drug off-label to adult LEMS patients, due to lower direct drug pricing, the analyst adds. "Clearly, someone at the FDA must have conducted this calculus and, in our opinion, ignored the purpose and meaning of the Act," says Duncan.