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Biosciences","amount2":0.39000000000000001,"highestDevelopmentShortName":"Preclinical","therapeuticAreaShortName":"Sleep","amount2New":0.39000000000000001,"dosageForm":"","sponsorNew":"Harmony Biosciences \/ Harmony Biosciences","highestDevelopmentStatusID":"4","companyTruncated":"Harmony Biosciences \/ Harmony Biosciences"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Epygenix Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"","productType":"Small molecule","year":"2024","type":"Acquisition","leadProduct":"Clemizole hydrochloride","moa":"","graph1":"Neurology","graph2":"Phase II","graph3":"Harmony Biosciences","amount2":0.68000000000000005,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Neurology","amount2New":0.68000000000000005,"dosageForm":"Solution","sponsorNew":"Harmony Biosciences \/ Harmony Biosciences","highestDevelopmentStatusID":"8","companyTruncated":"Harmony Biosciences \/ Harmony Biosciences"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Pitolisant Hydrochloride","moa":"","graph1":"Sleep","graph2":"Approved","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"","sponsorNew":"Harmony Biosciences \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Harmony Biosciences \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals by Harmony Biosciences

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                          Therapeutic Area by Lead Product

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                          Top Deals by Deal Size (USD bn)

                          01

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.

                          Brand Name : Wakix

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          June 24, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : The acquisition enhances Harmony's strategy by adding a rare epilepsy franchise, including EPX-100, a potent oral 5HT2 agonist, to its innovative CNS pipeline.

                          Brand Name : EPX-100

                          Molecule Type : Small molecule

                          Upfront Cash : $35.0 million

                          April 30, 2024

                          Lead Product(s) : Clemizole hydrochloride

                          Therapeutic Area : Neurology

                          Highest Development Status : Phase II

                          Recipient : Epygenix Therapeutics

                          Deal Size : $680.0 million

                          Deal Type : Acquisition

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                          03

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Through the Licensing Agreement, Bioprojet will develop, manufacture, and commercialize TPM-1116, a selective oral orexin-2 receptor agonist for narcolepsy and other sleep/wake disorders.

                          Brand Name : TPM-1116

                          Molecule Type : Small molecule

                          Upfront Cash : $25.5 million

                          April 11, 2024

                          Lead Product(s) : TPM-1116

                          Therapeutic Area : Sleep

                          Highest Development Status : Preclinical

                          Recipient : Bioprojet Pharma

                          Deal Size : $393.0 million

                          Deal Type : Licensing Agreement

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                          04

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.

                          Brand Name : Wakix

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 03, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.

                          Brand Name : Wakix

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 20, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Wakix (pitolisant HCl) is a 5-HT3 receptor Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of adult patients with myotonic dystrophy type 1.

                          Brand Name : Wakix

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 07, 2023

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.

                          Brand Name : Wakix

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 13, 2023

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Through the acquisition, Harmony gets the opportunity to advance the development of a treatment for the symptoms of Fragile X syndrome and other rare neuropsychiatric disorders including, Zygel, the first and only pharmaceutically manufactured, synthetic...

                          Brand Name : Zygel

                          Molecule Type : Small molecule

                          Upfront Cash : $200.0 million

                          October 11, 2023

                          Lead Product(s) : Cannabidiol

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Recipient : Zynerba Pharmaceuticals

                          Deal Size : $200.0 million

                          Deal Type : Acquisition

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                          09

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.

                          Brand Name : Wakix

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 07, 2023

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : Through the acquisition, Harmony gets the opportunity to advance the development of a treatment for the symptoms of Fragile X syndrome and other rare neuropsychiatric disorders including, Zygel, the first and only pharmaceutically manufactured, synthetic...

                          Brand Name : Zygel

                          Molecule Type : Small molecule

                          Upfront Cash : $200.0 million

                          August 14, 2023

                          Lead Product(s) : Cannabidiol

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Recipient : Zynerba Pharmaceuticals

                          Deal Size : $200.0 million

                          Deal Type : Acquisition

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