A federal court judge recommended tossing a lawsuit filed by Catalyst Pharmaceuticals (CPRX) that accused the Food and Drug Administration of violating the law when it approved a similar medicine by a small, family-run rival company.
The move is a blow to Catalyst in its unusual battle with the agency, which has raised thorny questions about regulatory standards and the vagaries of orphan drug designations, while also playing into the heated national debate over the rising cost of prescription medicines. Investors sent its stock down nearly 12% in mid-day trading on the news.
At issue is the FDA approval in May 2019 of a Jacobus Pharmaceuticals drug used to treat a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS, that afflicts a few hundred to a few thousand people in the U.S. With its endorsement, the FDA provided Catalyst with unexpected competition after winning approval for its own medicine just months earlier.
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