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Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Umbralisib, a novel next generation inhibitor of PI3K delta CK1 epsilon, was discovered by Rhizen Pharmaceuticals and subsequently licensed to TG Therapeutics, who led the asset s clinical development.
Rhizen and its affiliate Alembic Pharma to support TG Therapeutics towards UKONIQ s commercialization as its manufacturing supply partner; Rhizen plans to register and commercialize Umbralisib in India.
Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of: