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Find Clinical Drug Pipeline Developments & Deals for Risdiplam

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: PTC Therapeutics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 12, 2020

            Details:

            SUNFISH Part 1 showed risdiplam significantly improved motor function after 24 months of treatment in people aged 2-25 years with Types 2 or 3 SMA.

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 28, 2020

            Details:

            Part 2 of pivotal study met its primary endpoint by demonstrating unsupported sitting in infants aged 1-7 months with type 1 SMA after 12 months of treatment.

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2020

            Details:

            U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2.

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 06, 2020

            Details:

            Risdiplam is the first SMA treatment to have positive placebo-controlled data in pivotal studies across a real world population of infants, children, teenagers and adults

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 23, 2020

            Details:

            The single-arm part 2 of FIREFISH study assessed the efficacy of risdiplam in 41 infants with type 1 SMA treated for 12 months. Study meets primary endpoint in patients living with type 1 SMA.

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 23, 2020

            Details:

            Risdiplam demonstrated statistically significant and medically meaningful motor milestone improvement in infants with Type 1 SMA

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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 23, 2020

            Details:

            Risdiplam demonstrated statistically significant and medically meaningful motor milestone improvement in infants with Type 1 SMA