REGENXBIO Aligns with FDA for NAVSUNLI Accelerated Approval Path, Q3 BLA Resubmission Planned
Summary
REGENXBIO has aligned with the FDA on the next steps for potential accelerated approval of its drug NAVSUNLI. This follows earlier reports of the FDA reversing its prior rejection. The company expects a Type A meeting in July and plans to resubmit the Biologics License Application (BLA) rapidly in Q3 2026. This provides a clear and accelerated pathway for a key pipeline asset, which is a significant positive development for the company, especially given its recent Q1 losses and going concern doubts.
At the time of this announcement, RGNX was trading at $8.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $403.2M. The 52-week trading range was $5.46 to $16.19. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.