Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Catalyst Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Pharma Sub-Licensee Gets Approval For FIRDAPSE® in Japan
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that received approval to treat Lambert-Eaton myasthenic syndrome in Japan.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 24, 2024
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Catalyst Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that recieved FDA approval for its max dose to treat Lambert-Eaton myasthenic syndrome.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 30, 2024
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : DyDo Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 18, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : DyDo Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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).
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 23, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : KYE Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : A favorable decision from the Federal Court of Canada setting aside second time decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients.
Brand Name : Ruzurgi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 11, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : KYE Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Merck & Co
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Pharmaceuticals Further Strengthens FIRDAPSE® U.S. Patent Portfolio
Details : FIRDAPSE® (amifampridine phosphate) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium channel blocker that causes depolarization of presynaptic membrane and slows or inhibits repolarization for treatment of adults with Lambert-Eaton my...
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 02, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Merck & Co
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : U.S. FDA approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product) for the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome ("LEMS") violated Catalyst's exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg u...
Brand Name : Ruzurgi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 03, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Firdapse® (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is commercially available in the United States as a treatment for adults with LEMS.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2021
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : DyDo Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : DyDo Pharma will have joint rights to develop Firdapse® (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan. Firdapse® is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that slows or inhibits ...
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 28, 2021
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : DyDo Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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