Regenxbio CEO: FDA Agrees to Reconsider Gene Therapy Application
Regenxbio (RGNX) Chief Executive Curran Simpson said the Food and Drug Administration has agreed to reverse its rejection of an experimental gene therapy for a rare and fatal brain disease and that Regenxbio plans to refile its application seeking approval of its Navsunli gene therapy in the third quarter, after it holds a formal meeting to resolve disputes with the FDA that is expected in July, according to The Wall Street Journal's Xavier Martinez. Another biotech, Replimune (REPL), reached an agreement with the FDA last month to resubmit its twice-rejected melanoma therapy and earlier this month uniQure (QURE) said the FDA had reversed course on its Huntington's disease gene therapy.
