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Catalyst Pharmaceuticals Inc (CPRX.OQ)

CPRX.OQ on NASDAQ Stock Exchange Capital Market

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7 Dec 2018
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Latest Key Developments (Source: Significant Developments)

FDA Grants Approval Of Firdapse To Catalyst Pharmaceuticals
Wednesday, 28 Nov 2018 

Nov 28 (Reuters) - U.S. Food and Drug Administration::FDA APPROVES FIRST TREATMENT FOR LAMBERT-EATON MYASTHENIC SYNDROME, A RARE AUTOIMMUNE DISORDER.FDA SAYS GRANTED APPROVAL OF FIRDAPSE TO CATALYST PHARMACEUTICALS INC.  Full Article

Catalyst Pharmaceuticals Announces Firdapse (Amifampridine) New Drug Application Continues Under Review
Tuesday, 27 Nov 2018 

Nov 27 (Reuters) - Catalyst Pharmaceuticals Inc ::CATALYST PHARMACEUTICALS ANNOUNCES FIRDAPSE® (AMIFAMPRIDINE) NEW DRUG APPLICATION CONTINUES UNDER REVIEW.CATALYST PHARMACEUTICALS INC - NO DECISION HAS YET BEEN RECEIVED FROM FDA WITH RESPECT TO COMPANY'S NEW DRUG APPLICATION FOR FIRDAPSE.CATALYST PHARMA - CONTRACTOR WORKING ON A WEB PAGE UNINTENTIONALLY ALLOWED LIVE SCREEN TO BE SEEN SHOWING POSSIBLE APPROVAL OF CO'S NDA ALREADY RECEIVED.  Full Article

Catalyst Pharmaceuticals Q2 GAAP Loss Per Share $0.06
Tuesday, 7 Aug 2018 

Catalyst Pharmaceuticals Inc ::CATALYST PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q2 GAAP LOSS PER SHARE $0.06.Q2 EARNINGS PER SHARE VIEW $-0.08 -- THOMSON REUTERS I/B/E/S.POTENTIAL LAUNCH OF FIRDAPSE FOR LEMS IN EARLY 2019.EXPECTS THAT COSTS RELATED TO RESEARCH AND DEVELOPMENT ACTIVITIES WILL CONTINUE TO BE SUBSTANTIAL THROUGHOUT 2018.CATALYST PHARMACEUTICALS - BELIEVES EXISTING CAPITAL RESOURCES WILL BE SUFFICIENT TO SUPPORT PLANNED OPERATIONS THROUGH 2019.  Full Article

Catalyst Pharma Submits NDA For Firdapse
Thursday, 29 Mar 2018 

March 29 (Reuters) - Catalyst Pharmaceuticals Inc ::CATALYST PHARMACEUTICALS ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION FOR FIRDAPSE® FOR TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME.CATALYST PHARMACEUTICALS - SUBMISSION OF NDA TO U.S. FDA FOR FIRDAPSE.  Full Article

Great Point Partners Reports 5.14 Pct Passive Stake In Catalyst Pharma
Friday, 8 Dec 2017 

Dec 8 (Reuters) - Catalyst Pharmaceuticals Inc ::GREAT POINT PARTNERS LLC REPORTS A 5.14 PERCENT PASSIVE STAKE IN CATALYST PHARMACEUTICALS INC AS OF NOV 28 - SEC FILING.  Full Article

Catalyst Pharma Announces Proposed Public Offering Of Common Stock
Monday, 27 Nov 2017 

Nov 27 (Reuters) - Catalyst Pharmaceuticals Inc ::CATALYST PHARMACEUTICALS, INC. ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK.SAYS OFFERING 11.0 MILLION COMMON SHARES.CATALYST-PLANS TO USE PROCEEDS TO FUND CLINICAL STUDIES OF FIRDAPSE FOR TREATMENT OF MUSK-ANTIBODY POSITIVE MYASTHENIA GRAVIS,SPINAL MUSCULAR ATROPHY​.- PLANS TO USE NET PROCEEDS FROM OFFERING TO FUND PRE-COMMERCIALIZATION ACTIVITIES FOR FIRDAPSE​.  Full Article

Catalyst Pharma Posts Positive Top-Line Results From Second Phase 3 Clinical Trial Of Firdapse
Monday, 27 Nov 2017 

Nov 27 (Reuters) - Catalyst Pharmaceuticals Inc ::CATALYST PHARMACEUTICALS ANNOUNCES POSITIVE TOP-LINE RESULTS FROM SECOND PHASE 3 CLINICAL TRIAL OF FIRDAPSE® IN PATIENTS WITH LAMBERT-EATON MYASTHENIC SYNDROME.CATALYST PHARMACEUTICALS INC - ‍TREATMENT WITH FIRDAPSE ACHIEVED STATISTICAL SIGNIFICANCE FOR CO-PRIMARY ENDPOINTS AND SECONDARY ENDPOINT​.CATALYST PHARMACEUTICALS INC - ‍POSITIVE RESULTS TO SUPPORT PLANNED NDA SUBMISSION IN Q1 OF 2018​.CATALYST PHARMACEUTICALS INC - ‍FIRDAPSE WAS SAFE AND WELL TOLERATED BY PATIENTS IN TRIAL​.  Full Article

Catalyst Pharmaceuticals posts Q3 loss per share $0.05
Wednesday, 8 Nov 2017 

Nov 8 (Reuters) - Catalyst Pharmaceuticals Inc :Catalyst Pharmaceuticals announces third quarter 2017 financial results and provides corporate update.Q3 GAAP loss per share $0.05.Q3 earnings per share view $-0.06 -- Thomson Reuters I/B/E/S.Catalyst Pharmaceuticals Inc - ‍expects pre-commercialization expenses to increase in Q4 of 2017​.  Full Article

Catalyst Pharmaceuticals completes enrollment in second Phase 3 trial of Firdapse®
Tuesday, 31 Oct 2017 

Oct 31 (Reuters) - Catalyst Pharmaceuticals Inc :Catalyst Pharmaceuticals completes enrollment in second Phase 3 trial of Firdapse® in patients with Lambert-Eaton Myasthenic Syndrome.Catalyst Pharmaceuticals Inc - ‍top-line results for Phase 3 trial of Firdapse expected in early December​.  Full Article

UPDATE 1-U.S. FDA approves Catalyst Pharma's rare disease drug

Nov 28 The U.S. Food and Drug Administration approved on Wednesday Catalyst Pharmaceuticals Inc's drug to treat a rare autoimmune disease.