FDA Clinical Hold on RGX-121 Sends Regenxbio Down 22%
RGNX sits 55% above its 52-week low of $5.455.
Summary
The FDA placed a clinical hold on Regenxbio's Hunter syndrome gene therapy RGX-121 after an expanded MRI program found asymptomatic spinal nodules in five patients who received the treatment 3-6 years ago. The company says the findings are likely benign and non-serious, but it does not expect to resubmit the BLA for RGX-121 in the near future. This is the second clinical hold for the company this year, following a similar hold on RGX-111 just weeks before a key approval decision. Shares plunged 22% to $8.34 in premarket trading, erasing much of the recent gains from the AbbVie milestone and Q2 profit. The setback raises doubts about the near-term approval path for the Hunter syndrome program, though the company still plans to submit a BLA for its Duchenne candidate this quarter.
At the time of this announcement, RGNX was trading at $8.47 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $707.7M. The 52-week trading range was $5.46 to $16.19. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.