By Denny Jacob

Y-mAbs Therapeutics' investigational new drug application for CD38-SADA was cleared by the Food and Drug Administration.

The commercial-stage biopharmaceutical company said CD38-SADA is its second program within its self-assembly disassembly pre-target radioimmunotherapy theranostic platform. The Phase 1 trial is investigating the safety and tolerability of the CD38-SADA: (177) Lu-DOTA Drug Complex in patients with relapsed or refractory non-Hodgkin lymphoma.

Interim Chief Executive Thomas Gad said the FDA's clearance marks the second program utilizing its SADA technology platform to enter clinic development within just 15 months.

Y-mAbs said it expects to dose the first patient in its Phase 1 trial in 2024.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

October 17, 2023 17:46 ET (21:46 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
Y mAbs Therapeutics (NASDAQ:YMAB)
Gráfica de Acción Histórica
De May 2024 a Jun 2024 Haga Click aquí para más Gráficas Y mAbs Therapeutics.
Y mAbs Therapeutics (NASDAQ:YMAB)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024 Haga Click aquí para más Gráficas Y mAbs Therapeutics.