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Biotech Stocks Facing FDA Decision In June 2024

Catalyst Pharmaceuticals
Catalyst Pharmaceuticals

The FDA decision on Catalyst Pharmaceuticals Inc.’s (CPRX) supplemental New Drug Application to increase the indicated maximum daily dosage of its flagship drug FIRDAPSE from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome is due on June 4, 2024.

FIRDAPSE Tablets 10 mg received FDA approval for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for children ages six to seventeen in November 2018.

The recommended starting dose is 15 mg to 30 mg daily taken orally in divided doses (3 to 4 times daily) and the dosage is not to exceed a maximum of 80 mg daily.

The drug, which is the only approved drug for LEMS in the U.S., generated net product revenue of $66.8 million in the first quarter of 2024, reflecting a 16.2% year-over-year increase.

CPRX closed Wednesday’s trading at $15.88, down 4.16%.