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Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
Details:
The DSMB noted that the trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2020
Details:
Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included results from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mt Sinai Hospital in March-April this year.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $1,355.0 million Upfront Cash: $50.0 million
Deal Type: Collaboration November 20, 2020
Details:
Addition of remestemcel-L could expand Novartis' respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2020
Details:
The Phase 3 trial aims to confirm findings from a pilot study at New York’s Mt Sinai Hospital where nine of 12 ventilator-dependent patients were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2020
Details:
Independent Data Safety Monitoring Board (DSMB) recommended continuation of the Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, following completion of trial’s first interim analysis.
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