The FDA Places Clinical Hold On Regenxbio's RGX-121 Following Asymptomatic Spine MRI Findings In Five Participants In CAMPSIITE Study In Mucopolysaccharidosis Type II Patients
REGENXBIO Inc. (NASDAQ:RGNX) today provided an update on its investigational gene therapy, RGX-121 (clemidsogene lanparvovec), for the treatment of Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome.
The FDA paused testing of a new medicine that was supposed to help kids with a rare disease because doctors saw unexpected spine changes on scans, even though the kids felt fine. When a medicine gets paused like this, it's a sign the company needs to figure out what happened and prove it's safe before continuing.
Last session drawn · prints held ~15 minutes · licensed exchange data
Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
Disclosure: Educational and informational purposes only — not financial advice. We educate, not advise. Market data may be delayed up to 15 minutes unless marked real-time. Past performance is not indicative of future results.