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    Find the latest Drugs in Development and Pipeline Prospector News of The Italfarmaco Group.

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    The Italfarmaco Group
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    ITALFARMACO S.p.A. V.le Fulvio Testi, 330 20126 Milan
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    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.


    Lead Product(s): Givinostat

    Therapeutic Area: Genetic Disease Product Name: ITF2357

    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 November 29, 2023

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    Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrophy and Receives Priority Review

    Details:

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


    Lead Product(s): Givinostat

    Therapeutic Area: Genetic Disease Product Name: ITF2357

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Syneos Health

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 29, 2023

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    Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Patients with Duchenne Muscular Dystroph...

    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 primary endpoint.


    Lead Product(s): Givinostat

    Therapeutic Area: Genetic Disease Product Name: ITF2357

    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 June 25, 2022

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    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.


    Lead Product(s): Givinostat

    Therapeutic Area: Genetic Disease Product Name: ITF2357

    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 09, 2020

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