The story
Catalyst was founded in 2002, and completed an IPO in 2006. It focused primarily on developing therapies to prevent addiction until 2012.
In 2009, Catalyst in-licensed worldwide rights to a family of GABA inhibitors including CPP-115 from Northwestern University. In 2012, it in-licensed patents covering the use of amifampridine phosphate to treat LEMS for the North American market from BioMarin.
In 2012, while BioMarin had a Phase III trial ongoing in the US, it licensed the US rights to 3,4-DAPP, including the orphan designation and the ongoing trial, to Catalyst Pharmaceuticals.
In August 2013, analysts anticipated that FDA approval would be granted to Catalyst in LEMS by 2015. The drug is used to treat Lambert–Eaton myasthenic syndrome (LEMS), which is a rare neuromuscular disorder characterized by muscle weakness of the limbs, affecting about 3.4 per million people.
In December 2015, Catalyst submitted its new drug application to the FDA, and in February 2016 the FDA refused to accept it, on the basis that it wasn't complete. In April 2016 the FDA told Catalyst it would have to gather further data. In March 2018 the company re-submitted its NDA. The FDA approved amifampridine for the treatment of adults with Lambert-Eaton myasthenic syndrome on November 29, 2018.
In 2018, Catalyst terminated its license for CPP-115 with Northwestern and stopped the development program for that compound.
As of 2022, the company offered Catalyst Pathways, a program that provides financial aid, insurance navigation, bridge medicine, and Patient Access Liaisons.
In January 2023, Catalyst acquired the US rights for the epilepsy drug FYCOMPA (perampanel). Fycoma had FDA approvals in 2016 with an oral suspension formulation and in 2017 for its use as a monotherapy.
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In October 2023, Patrick J. McEnany retired as CEO. He now serves as Chairman. Richard J. Daly was appointed as CEO on Jan 1, 2024.
In March 2024, Catalyst commercially launched AGAMREE (vamorolone) oral suspension for the treatment of Duchenne muscular dystrophy in patients aged two years and older. Catalyst had acquired the North American rights in July 2023. It had previously been approved by the FDA in October 2023.
In May 2024, the FDA approved a supplemental New Drug Application increasing the indicated maximum daily dose of Firdapse (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg.
From Wikipedia’s article on Catalyst Pharmaceuticals, shared under CC BY-SA 4.0.7