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Catalyst Pharmaceuticals
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Country
U.S.A
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Address
355 Alhambra Circle, Suite 801 Coral Gables, FL 33134
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Telephone
(305) 420-3200

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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.


Lead Product(s): Vamorolone

Therapeutic Area: Genetic Disease Product Name: Agamree

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 13, 2024

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Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.


Lead Product(s): Amifampridine Phosphate

Therapeutic Area: Immunology Product Name: Firdapse

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: DyDo Pharma

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 18, 2023

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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.


Lead Product(s): Vamorolone

Therapeutic Area: Genetic Disease Product Name: Agamree

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Santhera Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2023

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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.


Lead Product(s): Amifampridine Phosphate

Therapeutic Area: Immunology Product Name: Firdapse

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 13, 2023

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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).


Lead Product(s): Vamorolone

Therapeutic Area: Genetic Disease Product Name: VBP15

Highest Development Status: Phase IIProduct Type: Small molecule

Recipient: Santhera Pharmaceuticals

Deal Size: $231.0 million Upfront Cash: $75.0 million

Deal Type: Licensing Agreement July 19, 2023

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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.


Lead Product(s): Vamorolone

Therapeutic Area: Genetic Disease Product Name: VBP15

Highest Development Status: Phase IIProduct Type: Small molecule

Recipient: Santhera Pharmaceuticals

Deal Size: $231.0 million Upfront Cash: $90.0 million

Deal Type: Licensing Agreement June 20, 2023

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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").


Lead Product(s): Amifampridine

Therapeutic Area: Immunology Product Name: Firdapse

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 09, 2023

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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.


Lead Product(s): Perampanel

Therapeutic Area: Neurology Product Name: Fycompa

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Eisai

Deal Size: Undisclosed Upfront Cash: $160.0 million

Deal Type: Acquisition January 25, 2023

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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).


Lead Product(s): Amifampridine Phosphate

Therapeutic Area: Immunology Product Name: Firdapse

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 23, 2023

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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.


Lead Product(s): Perampanel

Therapeutic Area: Neurology Product Name: Fycompa

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Eisai

Deal Size: Undisclosed Upfront Cash: $160.0 million

Deal Type: Divestment December 20, 2022

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