CATALYST PHARMACEUTICALS, INC. (NASDAQ:CPRX) Files An 8-K Other EventsItem 8.01 Other Events
On May29, 2018, the Company announced that its New Drug Application (NDA) for Firdapse® for the treatment of Lambert-Eaton Myasthenic Syndrome has been accepted for a Priority Review by the U.S. Food and Drug Administration.
The Company’s press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Item 8.01 Financial Statements and Exhibits.
| (d) | Exhibits |
| 99.1 | Press release issued by the Company on May29, 2018. |
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CATALYST PHARMACEUTICALS, INC. ExhibitEX-99.1 2 d593087dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Catalyst Pharmaceuticals Announces FDA Acceptance of NDA and Priority Review Status for Firdapse® (Amifampridine Phosphate) for Lambert-Eaton Myasthenic Syndrome PDUFA Date Set for November 28,…To view the full exhibit click here
About CATALYST PHARMACEUTICALS, INC. (NASDAQ:CPRX)
Catalyst Pharmaceuticals, Inc., formerly Catalyst Pharmaceutical Partners, Inc., is a development-stage biopharmaceutical company. The Company is focused on developing and commercializing therapies for people with rare debilitating diseases. The Company has three drugs in development: Firdapse, CPP-109 and CPP-115. The Company’s Firdapse is indicated for the treatments of lambert-eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS). Firdapse consists of the phosphate salt of amifampridine. The Company has completed the Phase III trial of Firdapse. The Company’s CPP-109 (vigabatrin) is a gamma-aminobutyric acid (GABA) aminotransferase inhibitor. CPP-109 is indicated for the treatment of Tourette’s Disorder. The Company’s CPP-115 is a GABA aminotransferase inhibitor. CPP-115 is indicated for the treatment of selected neurological indications, such as complex partial seizures and Tourette’s Disorder, and epilepsy.