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    [{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco 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Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Syneos Health","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic 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Applicable","leadProduct":"Givinostat HCl","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":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco 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    Find Clinical Drug Pipeline Developments & Deals by Italfarmaco S.p.A

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                            01

                            Italfarmaco S.p.A

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                            Immuno-Oncology 360
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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved FDF

                            Sponsor : Medis

                            Deal Size : Undisclosed

                            Deal Type : Agreement

                            DEALS_DEV arrow-down

                            Italfarmaco, Medis Sign Exclusive Deal for Givinostat in 17 European Nations

                            Details : Under the agreement, Medis will have exclusive distribution rights of Duvyzat (Givinostat HCl). It is being indicated for the treatment of DMD.

                            Product Name : Duvyzat

                            Product Type : Other Small Molecule

                            Upfront Cash : Undisclosed

                            March 18, 2025

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : Medis

                            Deal Size : Undisclosed

                            Deal Type : Agreement

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                            02

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            ITF Therapeutics Announces U.S. Availability of DUVYZAT™ for Duchenne Muscular Dystrophy

                            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.

                            Product Name : Duvyzat

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            July 25, 2024

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Italfarmaco S.p.A

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                            Immuno-Oncology 360
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                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
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                            Lead Product(s) : Undisclosed

                            Therapeutic Area : Neurology

                            Study Phase : Discovery Platform

                            Recipient : Iktos

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

                            DEALS_DEV arrow-down

                            Italfarmaco Partners with Iktos to Speed Drug Discovery with AI

                            Details : Italfarmaco collaborates with Iktos to develop next-generation, small molecule HDAC inhibitors for various non-oncological diseases, including diseases affecting the central nervous system.

                            Product Name : Undisclosed

                            Product Type : Small molecule

                            Upfront Cash : Undisclosed

                            June 18, 2024

                            Lead Product(s) : Undisclosed

                            Therapeutic Area : Neurology

                            Highest Development Status : Discovery Platform

                            Recipient : Iktos

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

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                            04

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy

                            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.

                            Product Name : Duvyzat

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            March 21, 2024

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Undisclosed

                            Therapeutic Area : Oncology

                            Study Phase : Discovery

                            Recipient : Nerviano Medical Sciences

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Nerviano Medical Sciences and Italfarmaco Announce Licensing of Linker-Payload Technology to Develop and Comme...

                            Details : Under the terms of the agreement, ITF will use NMS’s proprietary linker-payload technology to develop a novel peptide-drug conjugate (PDC) to bring first- and best-in-class personalized medicines to cancer patients.

                            Product Name : Undisclosed

                            Product Type : Peptide

                            Upfront Cash : Undisclosed

                            December 14, 2023

                            Lead Product(s) : Undisclosed

                            Therapeutic Area : Oncology

                            Highest Development Status : Discovery

                            Recipient : Nerviano Medical Sciences

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

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                            06

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA

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

                            Product Name : ITF2357

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            November 29, 2023

                            Lead Product(s) : Givinostat HCl

                            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

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Syneos Health

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrop...

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

                            Product Name : ITF2357

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 29, 2023

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Syneos Health

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat i...

                            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...

                            Product Name : ITF2357

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 25, 2022

                            Lead Product(s) : Givinostat HCl

                            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

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Italfarmaco Provides Update on Ongoing Clinical Programs with Givinostat in Oral Presentation at XVIII Interna...

                            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...

                            Product Name : ITF2357

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 22, 2021

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            10

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed

                            Italfarmaco S.p.A

                            Italy arrow
                            Immuno-Oncology 360
                            Not Confirmed
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Italfarmaco Gets FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy

                            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...

                            Product Name : ITF2357

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            October 09, 2020

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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