History

 

Founded in 2002, Catalyst is dedicated to making a meaningful impact in the lives of those suffering from rare diseases.

2002

Catalyst is founded and establishes its headquarters in Coral Gables, Florida.

2006

Catalyst successfully completes its Initial Public Offering (IPO).

2006-2012

Catalyst focuses on developing therapies to prevent stimulant dependence.

2009

Catalyst partners with Northwestern University and in-licenses worldwide rights to a family of GABA inhibitors CPP-115 enters preclinical development.

2010

CPP-115 is granted “Orphan Drug Designation” by the FDA for the treatment of infantile spasms.

2011

Catalyst licenses worldwide rights from NYU and FIMR to commercialize GABA inhibitors for the treatment of Tourette’s syndrome.

2012

CPP-115 is granted “Orphan Medicinal Product Designation” by the European Commission (EC).

Catalyst secures the North American rights to amifampridine from BioMarin.

2013

Catalyst opens 16 new clinical sites and expands the phase 3 LEMS development program for amifampridine.

Amifampridine is granted “Breakthrough Therapy Designation” by the FDA for the treatment of LEMS.

2002

Catalyst is founded and establishes its headquarters in Coral Gables, Florida.

2006

Catalyst successfully completes its Initial Public Offering (IPO).

2006-2012

Catalyst focuses on developing therapies to prevent stimulant dependence.

2009

Catalyst partners with Northwestern University and in-licenses worldwide rights to a family of GABA inhibitors CPP-115 enters preclinical development.

2010

CPP-115 is granted “Orphan Drug Designation” by the FDA for the treatment of infantile spasms.

2011

Catalyst licenses worldwide rights from NYU and FIMR to commercialize GABA inhibitors for the treatment of Tourette’s syndrome.

2012

CPP-115 is granted “Orphan Medicinal Product Designation” by the European Commission (EC).

Catalyst secures the North American rights to amifampridine from BioMarin.

2013

Catalyst opens 16 new clinical sites and expands the phase 3 LEMS development program for amifampridine.

Amifampridine is granted “Breakthrough Therapy Designation” by the FDA for the treatment of LEMS.

2014

Catalyst announces the initiation of the amifampridine Expanded Access Program (EAP).

Catalyst announces positive top-line phase 3 data from amifampridine in patients with LEMS.

Amifampridine phase 3 trial results presented at the 61st Annual Meeting of AANEM.

2015

Catalyst completes pre-NDA meeting with the FDA.

Amifampridine is granted orphan drug designation by the FDA for the treatment of CMS.

Catalyst files initial NDA for amifampridine for the treatment of LEMS and CMS.

2016

The FDA requests additional support, issues a “Refuse to File” letter in response to the NDA filing.

Catalyst supports the first Investigator-Initiated Trial of amifampridine in patients with MuSK-MG.

Catalyst initiates enrollment in CMS-001, a phase 2/3 clinical trial in children aged 2 years and older with CMS.

Catalyst revises CMS-001 trial protocol to include adults with CMS.

Catalyst initiates enrollment in LMS-003, a second phase 3 clinical trial of amifampridine in patients with LEMS.

2017

Positive data is reported from an Investigator-Sponsored Trial of amifampridine in patients with MuSK-MG.

Catalyst initiates and completes enrollment for the second phase 3 trial of amifampridine in patients with LEMS.

2018

Catalyst submits an NDA for FDA approval of amifampridine for use in treating LEMS.

In November Catalyst gains FDA approval of amifampridine for the treatment of LEMS in adults.

AANEM=American Association of Neuromuscular & Electrodiagnostic Medicine; CMS=congenital myasthenic syndromes; FIMR=Feinstein Institute for Medical Research; MuSK-MG=muscle-specific receptor tyrosine kinase myasthenia gravis; NYU=New York University.

2014

Catalyst announces the initiation of the amifampridine Expanded Access Program (EAP).

Catalyst announces positive top-line phase 3 data from amifampridine in patients with LEMS.

Amifampridine phase 3 trial results presented at the 61st Annual Meeting of AANEM.

2015

Catalyst completes pre-NDA meeting with the FDA.

Amifampridine is granted orphan drug designation by the FDA for the treatment of CMS.

Catalyst files initial NDA for amifampridine for the treatment of LEMS and CMS.

2016

The FDA requests additional support, issues a “Refuse to File” letter in response to the NDA filing.

Catalyst supports the first Investigator-Initiated Trial of amifampridine in patients with MuSK-MG.

Catalyst initiates enrollment in CMS-001, a phase 2/3 clinical trial in children aged 2 years and older with CMS.

Catalyst revises CMS-001 trial protocol to include adults with CMS.

Catalyst initiates enrollment in LMS-003, a second phase 3 clinical trial of amifampridine in patients with LEMS.

2017

Positive data is reported from an Investigator-Sponsored Trial of amifampridine in patients with MuSK-MG.

Catalyst initiates and completes enrollment for the second phase 3 trial of amifampridine in patients with LEMS.

2018

Catalyst submits an NDA for FDA approval of amifampridine for use in treating LEMS.

In November Catalyst gains FDA approval of amifampridine for the treatment of LEMS in adults.

AANEM=American Association of Neuromuscular & Electrodiagnostic Medicine; CMS=congenital myasthenic syndromes; FIMR=Feinstein Institute for Medical Research; MuSK-MG=muscle-specific receptor tyrosine kinase myasthenia gravis; NYU=New York University.

Pipeline

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Management

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Board of Directors

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