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Catalyst Pharmaceuticals Inc (CPRX.O)

CPRX.O on Consolidated Issue listed on NASDAQ Capital Market

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23 Jan 2017
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Latest Key Developments (Source: Significant Developments)

Catalyst Pharmaceuticals updates on trial for patients with congenital myasthenic syndromes
Thursday, 8 Dec 2016 08:03am EST 

Catalyst Pharmaceuticals Inc : Allowing Adult CMS patients to participate in trial . "Continue to believe that we will report top-line results from this study in second half of 2017" . Number of patients increased to approximately 20 .Provides update on its clinical trial for patients with congenital myasthenic syndromes.  Full Article

Catalyst Pharmaceuticals gets FDA special protocol assessment for phase 3 trial of lems treatment
Monday, 31 Oct 2016 08:03am EDT 

Catalyst Pharmaceuticals Inc : Says intends to conduct its second phase 3 trial (designated as lms-003) at two clinical trial sites . FDA has agreed to allow Catalyst to enroll patients from its expanded access program as study subjects in this second trial .Receives special protocol assessment (SPA) from the FDA for second phase 3 clinical trial evaluating firdapse for the treatment of lems.  Full Article

Catalyst Pharmaceuticals announce Q2 2016 financial results and provides product development update
Tuesday, 9 Aug 2016 04:17pm EDT 

Catalyst Pharmaceuticals Inc : Catalyst Pharmaceuticals announces second quarter 2016 financial results and provides product development update . Q2 earnings per share view $-0.08 -- Thomson Reuters I/B/E/S . Q2 GAAP loss per share $0.06 .Q2 non-GAAP loss per share $0.06 excluding items.  Full Article

Catalyst Pharma finalizes late-stage trial design with FDA for Firdapse
Monday, 13 Jun 2016 08:31am EDT 

Catalyst Pharmaceuticals Inc : Catalyst Pharmaceuticals announces agreement with FDA on confirmatory phase 3 study protocol for Firdapse in Lambert-Eaton Myasthenic Syndrome . Expects to initiate a small, single-center study with Firdapse during second half of 2016 .Existing capital resources are adequate to get us to an accepted NDA submission without need for additional financing.  Full Article

Catalyst Pharmaceuticals announces reduction in workforce
Tuesday, 17 May 2016 08:03am EDT 

Catalyst Pharmaceuticals Inc : Announces reduction in workforce as part of operating expense management plan . Reducing its workforce by approximately 30% . Expects to complete reduction in workforce immediately . Reduction in workforce affects employees from Catalyst's commercial team . Believe currently available resources will be sufficient to complete development of and refile NDA for firdapse for lems, cms .Reduction in workforce is part of ongoing efforts to conserve cash to complete requirements for NDA submission of Firdapse.  Full Article

Catalyst Pharmaceuticals posts Q1 GAAP loss of $0.07/shr
Tuesday, 10 May 2016 04:56pm EDT 

Catalyst Pharmaceuticals Inc : Believe current resources give sufficient runway for at least next year . Continue to believe available resources will be sufficient to complete development of firdapse, refile nda for firdapse . Catalyst pharmaceuticals announces first quarter 2016 financial results and provides corporate update . Q1 gaap loss per share $0.07 . Q1 earnings per share view $-0.07 -- Thomson Reuters I/B/E/S .Q1 non-gaap loss per share $0.07 excluding items.  Full Article

Catalyst Pharmaceuticals announces top-line results in Phase 1 Trial of CPP-115
Wednesday, 16 Dec 2015 08:36am EST 

Catalyst Pharmaceuticals Inc:Says main adverse effect of prolonged elevated brain gaba, somnolence, was also observed.Results showed significant increases in brain levels of surrogate marker for potential efficacy, gamma-aminobutyric acid.Says expect to receive the full results of this study early next year.  Full Article

Catalyst Pharmaceuticals announces intent to develop generic equivalent of Sabril
Wednesday, 9 Sep 2015 08:03am EDT 

Catalyst Pharmaceuticals Inc:Announced the initiation of a project to develop a generic equivalent of Sabril.  Full Article

Catalyst Pharmaceuticals announces FDA Orphan Drug Designation of Firdapse for Treatment of Congenital Myasthenic Syndromes
Thursday, 5 Mar 2015 10:35am EST 

Catalyst Pharmaceutical Partners Inc:Says the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for Firdapse(tm) for treatment of patients with Congenital Myasthenic Syndromes (CMS).  Full Article

Catalyst Pharmaceutical Partners Inc announces closing of previously announced public offering
Monday, 9 Feb 2015 10:10am EST 

Catalyst Pharmaceutical Partners Inc:Closes its public offering of shares of its common stock.Sold 11,500,000 shares of its common stock in the offering, which includes 1,500,000 shares that were issued upon the full exercise by the underwriters of their over-allotment option.Offering price was $3.25 per share, and the net proceeds from the sale of the shares is expected to be about $34.7 mln.Piper Jaffray & Co. acted as the sole lead book-running manager and SunTrust Robinson Humphrey acted as the passive book-running manager with respect to this offering.Further, Roth Capital Partners and H.C. Wainwright & Co. acted as the lead co-manager and co-manager, respectively.  Full Article

BRIEF-Catalyst Pharmaceuticals announces Q3 2016 financial results

* Catalyst Pharmaceuticals-continues to believe currently available resources will be sufficient to complete development of Firdapse