Regenxbio Investor Sues Over FDA Hold on Rare Disorder Therapy

Regenxbio Inc. overhyped the safety and efficacy of its rare genetic-disease treatment to investors before regulators paused its study, an investor’s proposed class action said.

The company’s stock price plummeted almost 18% to close at $11.01 Jan. 28, the day the biotechnology company said the US Food and Drug Administration placed a clinical hold on its investigational gene therapy for Hurler syndrome, a disorder that leads to an abnormally high accumulation of complex sugars in cells, causing organ damage.

The FDA suspension on its study of RGX-111 followed a preliminary analysis of a tumor in a patient treated in its ...