Catalyst Pharmaceuticals Announces FDA Acceptance Of The Supplemental New Drug Application For FIRDAPSE
Portfolio Pulse from Benzinga Newsdesk
Catalyst Pharmaceuticals (NASDAQ:CPRX) has announced that the FDA has accepted for review its supplemental New Drug Application (sNDA) to increase the maximum daily dosage of FIRDAPSE from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The FDA has assigned a target action date of June 4, 2024. FIRDAPSE is currently approved in the U.S. for the treatment of LEMS in adults and children aged six to seventeen.
October 13, 2023 | 12:05 pm
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Catalyst Pharmaceuticals' sNDA for an increased dosage of FIRDAPSE has been accepted by the FDA. This could potentially expand the patient base for the drug if approved.
The acceptance of the sNDA by the FDA is a positive development for Catalyst Pharmaceuticals. If the increased dosage is approved, it could potentially expand the patient base for FIRDAPSE, which would likely lead to increased sales and revenue for the company. This could have a positive impact on the company's stock price in the short term.
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