Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics, has secured USFDA accelerated approval for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen; and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

Rhizen and its affiliate Alembic Pharma will support TG Therapeutics towards UKONIQ's commercialization as its manufacturing & supply partner; Rhizenplans to register and commercialize Umbralisib in India.

Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1(CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics at an IND stage (TGR 1202) in 2012.

In 2014, both parties entered into a licensing agreement as a part of which TGTX obtained worldwide rights and Rhizen has retained commercialization rights for India while also being the manufacturing and supply partner for Umbralisib.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.