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0.00181488203266784 0 0.000907441016333919 -0.00998185117967343 -0.00045372050816704 0.00771324863883839 0.00725952813067135 0.0235934664246824
Stock impact report

Regenxbio gene therapy trials suspended by FDA over safety worries [Yahoo! Finance]

REGENXBIO Inc. (RGNX) 
Last regenxbio inc. earnings: 2/26 04:05 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.regenxbio.com
Company Research Source: Yahoo! Finance
Regenxbio lost almost a fifth of its value Wednesday after the Food and Drug Administration placed a clinical hold on two of the company's experimental gene therapies. Regulators acted after researchers found a case of brain cancer in a 5-year-old child who had received one of the treatments, RGX-111, four years earlier. The agency decided to extend the hold to the second therapy, RGX-121, because of similarities between the two and “shared risk between the clinical studies,” Regenxbio said Wednesday. The company said there has been no causal link between RGX-111 and the child's condition and emphasized that RGX-121 is a separate therapy with years of safety data. "We are surprised by FDA's decision to place our RGX-121 program on hold while the investigation of this single, inconclusive incident in RGX-111 continues," CEO Curran Simpson said in the statement. The news is “confusing and unexpected,” Leerink Partners analyst Mani Foroohar wrote in a note to clients. The hold com Show less Read more
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