A five-year-old patient dosed with RGX-111 has developed a brain tumour four years after being dosed with the gene therapy.
REGENXBIO (RGNX) stock plunges after FDA clinical hold on RGX-111/RGX-121 gene therapies over a tumor case. Read more here.
Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...
A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including ...
REGENXBIO shares sink after the FDA places a clinical hold on two gene therapy trials following a safety concern tied to ...
The development of a brain tumor in a study participant led regulators to suspend a Hurler syndrome therapy in early testing ...
An AAV vector genome integration event associated with PLAG1 overexpression was identified in a preliminary analysis of the resected tumor.
REGENXBIO Inc.  today announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of MPS I, also known as Hurler ...
The company said that the FDA hold has impacted two experimental gene therapies, RGX-111 and RGX-121. ・REGENXBIO added that ...
Leerink said the premarket selloff in shares underscores the degree of surprise on the news, feeding into the "FDA ...
Investing.com -- REGENXBIO Inc. (NASDAQ:RGNX) stock fell 28% Wednesday after the FDA placed clinical holds on two of its ...
The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which ...