Shares of Regenxbio (NASDAQ: RGNX) rose as much as 37% in premarket trading after the Wall Street Journal reported that the Food and Drug Administration has agreed to reverse its rejection of the company's rare-disease drug.

Regenxbio plans to refile its application seeking approval of its Navsunli gene therapy in the third quarter, following a formal meeting with the FDA expected in July to resolve outstanding disputes, according to the Wall Street Journal.