REGENXBIO Inc. (RGNX) gained today after the company announced that the U.S. FDA has agreed that no additional studies are required for the resubmission of the BLA for NAVSUNLI, its one-time gene therapy for Hunter syndrome (MPS II).
NAVSUNLI (clemidsogene lanparvovec-sngl, RGX-121) is being developed as the first potential gene therapy for MPS II, a rare and progressive neurodegenerative disorder that primarily affects young boys.
FDA Alignment of Accelerated Approval Pathway
During a recent collaborative discussion with the agency, held as part of REGENXBIO's appeal of the February 2026 NAVSUNLI Complete Response Letter, the FDA confirmed that the existing longer-term biomarker and clinical data from the CAMPSIITE study are sufficient to support consideration under the accelerated approval pathway.
The FDA also stated that REGENXBIO does not need to enroll additional patients or conduct new studies, including the previously suggested untreated control arm.The agency has asked the company to request a Type A meeting to review the existing dataset and then resubmit the BLA immediately afterward.
Following resubmission, the FDA indicated it will conduct an expedited review, with labeling discussions beginning shortly thereafter.
Next Steps and Expected Timeline
REGENXBIO expects the Type A meeting to take place in July 2026, with a BLA resubmission planned for the third quarter of 2026.
Community Response
The National MPS Society welcomed the update, noting that Hunter syndrome remains a devastating and progressive condition with significant unmet medical needs. The organization expressed appreciation for the FDA's willingness to expedite review so that patients may gain access to a potentially transformative one-time therapy.
RGNX has traded between $5.45 and $161.90 over the past year. The stock closed Thursday's trading (June 18, 2026) at $7.80, down 1.27%. In pre-market trading, the stock is at $8.77, up 12.44%.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.