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Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"The Italfarmaco Group \/ Syneos Health","highestDevelopmentStatusID":"10","companyTruncated":"The Italfarmaco Group \/ Syneos Health"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Givinostat","moa":"","graph1":"Genetic Disease","graph2":"Approved","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"The Italfarmaco Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small 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                          01

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : PANTHERx partners with ITF for the U.S. distribution of Duvyzat (givinostat), the approved product to treat patients with all genetic variants of Duchenne muscular dystrophy aged six years and older.

                          Brand Name : Duvyzat

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          July 25, 2024

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Approved

                          Sponsor : ITF Therapeutics

                          Deal Size : Undisclosed

                          Deal Type : Partnership

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                          02

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.

                          Brand Name : Duvyzat

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          July 25, 2024

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.

                          Brand Name : Duvyzat

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          March 21, 2024

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : ITF2357 (givinostat) is an HDAC Inhibitor small molecule drug, currently being investigated as an oral suspension for the treatment of Duchenne Muscular Dystrophy.

                          Brand Name : ITF2357

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 29, 2023

                          Lead Product(s) : Givinostat

                          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

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : ITF2357 (givinostat) is an investigational drug act as a inhibits histone deacetylases (HDACs), which is investigated for the treatment of Duchenne Muscular Dystrophy.

                          Brand Name : ITF2357

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          June 29, 2023

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Syneos Health

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : The study compared ITF2357 (givinostat) to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional pr...

                          Brand Name : ITF2357

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          June 25, 2022

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : Italfarmaco provided evidence which continues to show a delay in disease progression in DMD boys aged 7-11 years at treatment start, supported by data on the 7-year follow-up period from the long-term study with Givinostat in addition to steroid treatmen...

                          Brand Name : ITF2357

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 22, 2021

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          Details : Third regulatory designation Italfarmaco has received from the FDA for Givinostat after the Orphan Drug designation and Fast Track designation and reflects the agency’s recognition of Givinostat’s potential to treat DMD, a devastating genetic disease...

                          Brand Name : ITF2357

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 09, 2020

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          Details : The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 27, 2020

                          Lead Product(s) : Givinostat

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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