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Details:
Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier, which is being evaluated for the treatment of infants with pre-symptomatic spinal muscular atrophy.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2024
Details:
Under the agreement, Royalty Pharma acquires additional royalties on Evrysdi (risdiplam), a survival motor neuron 2 splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron protein deficiency.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $1,500.0 million Upfront Cash: $1,000.0 million
Deal Type: Agreement October 19, 2023
Details:
Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency, which is used for babies under two months old with spinal muscular atrophy.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2023
Details:
Evrysdi (risdiplam) is the only non-invasive spinal muscular atrophy therapy approved to treat people of all ages in the European Union now including babies from birth, Approval was based on interim data from ongoing RAINBOWFISH trial.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2023
Details:
Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency, which is used for babies under two months old with spinal muscular atrophy.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2023
Details:
Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2023
Details:
Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2023
Details:
Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2023
Details:
The study showed Evrysdi (risdiplam) led to a two-fold increase in median SMN protein levels versus baseline after 4 weeks of treatment in all patient groups, irrespective of previous treatment.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
New two-year Evrysdi data show improvement or maintenance of motor function in people with SMA, a progressive neuromuscular disease that can be fatal.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022
Details:
Preliminary efficacy and safety data showed that all babies treated with Evrysdi (risdiplam) for one-year or more were alive without permanent ventilation, maintained swallowing and feeding abilities, and had not required hospitalisation.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
As part of the label extension, the Evrysdi (Risdiplam) prescribing information has also been updated to include recent two-year pooled data from Parts 1 and 2 of the FIREFISH study, which demonstrate long-term efficacy and safety in symptomatic infants with Type 1 SMA.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
Infants treated with Evrysdi (risdiplam) maintained or continued to improve in measures of motor function, including their ability to sit without support for 5 and 30 seconds. 91% of infants treated with Evrysdi in the FIREFISH study were still alive at three years.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2022
Details:
Data showed 91% of infants treated with Evrysdi were alive after three years of treatment. Evrysdi-treated infants improved or maintain motor functions, including ability to swallow, sit without support, stand with support and walk while holding on, three years of treatment.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2022
Details:
Long-term efficacy data from the pivotal SUNFISH study for Evrysdi (risdiplam) confirm increases in motor function are sustained at three years while adverse events decreased over the same period.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Long-term efficacy data from pivotal SUNFISH study for for Evrysdi (risdiplam), a survival motor neuron 2 (SMN2) splicing modifier, confirm increases in motor function are sustained at three years while adverse events decreased over the same period with Type 2 or Type 3 SMA.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
Latest interim results from the RAINBOWFISH study demonstrate that the majority of babies treated with Evrysdi, a survival motor neuron 2 splicing modifier, for at least 12 months were able to sit, stand and walk within timeframes typical of healthy babies.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi (risdiplam) for at least one year were able to sit, stand and walk within timeframes typical of healthy babies, as well as maintain swallowing.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2022
Details:
Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi (risdiplam) for at least one year were able to sit, stand and walk within timeframes typical of healthy babies, as well as maintain swallowing.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2022
Details:
Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2021
Details:
Evrysdi is designed to distribute evenly to all parts of the body, including the central nervous system. Evrysd is administered daily at home in liquid form by mouth or feeding tube. Evrysdi has been approved in over 50 countries including the U.S, European Union and Japan.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
Evrysdi is designed to treat SMA by increasing and sustaining the production of the SMN protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
Evrysdi has been approved for the treatment of patients with SMA, aged 2 months and older by the FDA and the EMA. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2021
Details:
Roche will present updated data from across the extensive EVRYSDI™ (risdiplam) clinical development programme, designed to represent a broad spectrum of people living with SMA, including those who have previously been treated with another SMA medication.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
Evrysdi has proven efficacy in adults, children and babies two months and older and is now approved in 44 countries worldwide. Pre-symptomatic babies with SMA treated with Evrysdi for at least one year were able to sit, stand and walk in RAINBOWFISH study.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2021
Details:
Genentech will present data from five studies from the Evrysdi clinical development program, which was designed to represent a broad spectrum of people living with SMA.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
Details:
Approval for Evrysdi from the European Medicines Agency was received for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: $490.0 million Upfront Cash: $30.0 million
Deal Type: Collaboration April 01, 2021
Details:
Evrysdi has proven efficacy in adults, children and babies two months and older. The approval is based on data from two clinical studies FIREFISH in symptomatic Type 1 infants aged 2 to 7 months and SUNFISH in symptomatic Type 2 and 3 in 2 to 25 years.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2021
Details:
These results demonstrated that Evrysdi patients sustained or improved in motor function after 24 months of treatment. Furthermore, the patients and caregivers reported improvements in their ability to function independently as well as their ability to complete daily tasks.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: PTC Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2021
Details:
The SMA Foundation–PTC partnership will provide funding, managed by the SMA Foundation, to academic institutions and other collaborators to advance foundational research in the area of regenerative medicine.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Spinal Muscular Atrophy Foundation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 09, 2021
Details:
Evrysdi is indicated for the treatment of 5q SMA in patients 2 months of age and older, with a clinical diagnosis of Type 1, Type 2 or Type 3 SMA or with one to four SMN2 copies.
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
Data showed that patients treated with Evrysdi at 12 months demonstrated significant improvement in survival and developmental milestones, including the ability to survive without permanent ventilation, and the ability to sit without support for at least five seconds.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
The application is based on the results from two positive studies evaluating risdiplam in Types 1, 2 and 3 spinal muscular atrophy across infants and adults.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
The milestone payment was triggered by the first commercial sale of Evrysdi™ (risdiplam) in the U.S. Evrysdi™ was approved by the Food and Drug Administration (FDA) on Aug. 7, for the treatment of spinal muscular atrophy in adults and children 2 months of age and older.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: $490.0 million Upfront Cash: $30.0 million
Deal Type: Licensing Agreement August 26, 2020
Details:
The submission is based on data from the dose-finding Part 1 and confirmatory Part 2 of the FIREFISH and SUNFISH studies which checked efficacy & safety of Evrysdi in symptomatic infants with type 1 SMA aged 2 to 7 months and in people with types 2 or 3 SMA aged 2 to 25 years.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
Evrysdi showed clinically meaningful improvements in motor function and obtainment of developmental milestones across two trials in patients age two months and above and across all levels of disease severity, including types 1, 2, and 3 SMA.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2020
Details:
The approval is based on data from two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2 to 7 months; and SUNFISH in children and adults aged 2 to 25 years.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Evrysdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2020
Details:
Risdiplam, to be marketed by Roche, is an investigational, orally administered survival motor neuron-2 (SMN2) splicing modifier for the treatment of spinal muscular atrophy (SMA).
Lead Product(s): Risdiplam
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $650.0 million Upfront Cash: $650.0 million
Deal Type: Acquisition July 20, 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.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: PTC Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 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.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
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 April 28, 2020
Details:
U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
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 April 07, 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
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 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.
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct 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
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct 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
Lead Product(s): Risdiplam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2020
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