Nurix Therapeutics Says FDA Places Partial Clinical Hold on NX-2127 Phase 1 Trial
02 November 2023 - 8:16AM
Dow Jones News
By Stephen Nakrosis
Nurix Therapeutics on Wednesday said the Food and Drug
Administration placed a partial clinical hold on U.S. Phase 1
NX-2127-001 study evaluating NX-2127 in various B-cell
malignancies.
Nurix said NX-2127 is currently being evaluated in patients with
relapsed or refractory B cell malignancies.
The biopharmaceutical company said the hold comes after it
informed the FDA it intends transition to an improved manufacturing
process. None of the company's other drug programs are affected by
the NX-2127 manufacturing process improvement, it said.
Screening and enrollment of new study participants has been
paused, but patients currently enrolled may continue to receive
treatment in accordance with the ongoing study protocol, Nurix
said. The company also said it is working with the FDA to resolve
the partial clinical hold as soon as possible.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 01, 2023 17:01 ET (21:01 GMT)
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