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Clarity Pharmaceuticals

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CAMBODIA PHAR-MED 2020

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Clarity Pharmaceuticals opens SARTATE™ neuroblastoma clinical trial

Lead Product(s): 67Cu-SARTATE

Therapeutic Area: Oncology Product Name: 67Cu-SARTATE

Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 23, 2020

Details:

67Cu-SARTATE™ trial is a Peptide Receptor Radionuclide Therapy (PRRT) administered to paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial at MSK.

Clarity Pharmaceuticals

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Clarity Pharmaceuticals Announces that the US FDA Grants Rare Pediatric Disease Designation to 67Cu-SARTATE to Treat Neuroblastoma

Lead Product(s): 67Cu-SARTATE

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2020

Details:

Upon FDA marketing approval of 67Cu-SARTATE™ for neuroblastoma with RPD designation, Clarity may be eligible to receive a Priority Review Voucher (PRV), which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months.