Catalyst Pharmaceuticals Reports FDA Approval of AGAMREE (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera Pharmaceuticals - Seite 3

About Catalyst Pathways AGAMREE Patient Assistance Program

AGAMREE will be available in the U.S. and marketed by Catalyst, supported by its Catalyst Pathway Program. This comprehensive patient support program includes a dedicated, personalized support team that assists families throughout the AGAMREE treatment journey, from answering questions to coordinating financial assistance programs for eligible patients. For more information, caregivers and healthcare professionals can visit www.yourcatalystpathways.com or call 1-833-422-8259.

About Catalyst Pharmaceuticals

With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic diseases. Catalyst's flagship U.S. commercial product is FIRDAPSE (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for children ages six to seventeen. In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS. Finally, on July 18, 2023, Catalyst acquired an exclusive license for North America for AGAMREE (vamorolone) oral suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE previously received FDA Orphan Drug and Fast Track designations and was approved for commercialization in the U.S. FDA on October 26, 2023.

For more information about Catalyst Pharmaceuticals, Inc., visit the Company's website at www.catalystpharma.com. For Full Prescribing and Safety Information for FIRDAPSE, visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA, please visit www.fycompa.com.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether AGAMREE's commercialization by Catalyst in the U.S. will prove to be accretive to Catalyst, (ii) whether Catalyst and Santhera will successfully develop additional indications for AGAMREE and obtain the approvals required to commercialize the product in the licensed territory for those additional indications, (iii) whether, if AGAMREE is commercialized by Catalyst, the drug will be successfully integrated into Catalyst's business activities, and (iv) those factors described in Catalyst's Annual Report on Form 10-K for the 2022 fiscal year, Catalyst's Quarterly Report on Form 10-Q for the first quarter of 2023, and Catalyst's other filings with the SEC, could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.