June 22 (Reuters) - The U.S. Food and Drug Administration
will reverse its rejection of Regenxbio's ( RGNX ) rare-disease
gene therapy, Navsunli, as the drug developer works to resubmit
its application, the Wall Street Journal reported on Monday.
Shares of the drug developer were up 11% in premarket
trading.
Regenxbio ( RGNX ) will refile its application in the third quarter,
following a formal meeting with the agency expected in July, the
report said, citing CEO Curran Simpson.
In February, the FDA declined to approve Navsunli for Hunter
syndrome, citing uncertainty over the trial design.
Regenxbio ( RGNX ) could not immediately be reached for comment
outside regular business hours.