[{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals\u2019 Firdapse\u00ae (amifampridine phosphate) Receives Marketing Approval in Canada for Patients with LEMS","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Announces Notice of Allowance of a U.S. Patent Application for \"Methods of Administering 3,4-Diaminopyridine\"","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small 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Japan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Receives Positive Decision from Appeals Court That Supports Orphan Drug Exclusivity for Firdapse\u00ae for LEMS","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Reports that the FDA Marketing Approval Previously Granted for Ruzurgi\u00ae is No Longer Valid","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Further Strengthens FIRDAPSE\u00c2\u00ae U.S. Patent Portfolio","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"KYE Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce a Second Favorable Canadian Federal Court Ruling Setting Aside Approval of Ruzurgi\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for FIRDAPSE\u00ae Expanding Patient Population to Include Pediatric Patients","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Eisai","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$160.0 million","newsHeadline":"Catalyst Pharmaceuticals to Acquire U.S. Commercial Rights to FYCOMPA\u00c2\u00ae (Perampanel) CIII From Eisai Co., Ltd","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Eisai","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$160.0 million","newsHeadline":"Eisai to Divest Rights for Anti-Epileptic Drug Fycompa\u00ae (perampanel) CIII In United States to Catalyst Pharmaceuticals","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 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Find Clinical Drug Pipeline Developments & Deals by Catalyst Pharmaceuticals
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor and modifying its downstream activity, being developed for the treatment Duchenne muscular dystrophy in 2 yaers and older patients.
Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Agamree (vamorolone) is a novel drug candidate candidate, which binds to the same receptor as corticosteroids but modifying its downstream activity and as such is considered a dissociative anti-inflammatory drug. Vamorolone is being indicated for DMD.
Firdapse (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome and FDA recently accepted to review the Company's sNDA to increase the indicated maximum daily dosage of amifampridine tablets 10 mg from 80mg to 100mg.
Under the agreement, Catalyst gains commercialization rights in North America for VBP15 (vamorolone), an investigational drug candidate with a mode of action based on binding to the same receptor as glucocorticoids, in Duchenne muscular dystrophy (DMD).
Santhera will grant Catalyst exclusive commercialization rights to VBP15, an orally active dissociative steroidal anti-inflammatory agent, in North America and Santhera will continue to focus on European commercialization of vamorolone in duchenne muscular dystrophy.
Firdapse (amifampridine) is a broad spectrum potassium channel blocker. sNDA submission has been planned to increase indicated maximum dose for firdapse® from 80 mg per day to 100 mg per day for the treatment of lambert eaton myasthenic syndrome ("LEMS").
The completion of the acquisition, strengthens the company's Commercial Portfolio with the First and Only AMPA Receptor Antagonist Marketed Product for Epilepsy. Fycompa (perampanel), an oral medication, is a selective non-competitive AMPA receptor antagonist.
Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist used to treat partial-onset seizures with or without secondarily generalized seizures, and as adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy.
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