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• Safety concerns spur FDA to again halt testing of Regenxbio gene therapy
  Investigators detected masses on the spines of five patients who received its Hunter syndrome treatment, leading to the program’s second clinical hold this year.
  biopharma_dive · 1mo ago
• Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings
  The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.
  fiercebiotech · 1mo ago
• Capricor CEO won’t rule out legal action against FDA after negative adcomm
  After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior mot…
  biospace · 2mo ago
• Inhibrx delivers ‘differentiated’ cancer drug data; Fractyl starts diabetes gene therapy trial
  Inhibrx, the subject of recent buyout rumors, showed its drug might enhance the effects of Keytruda. Elsewhere, Capricor sued its cell therapy partner and Argenx got a revenue boost.
  biopharma_dive · 4mo ago
• STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug
  Capricor Therapeutics has accused Nippon Shinyaku and its U.S. subsidiary of botching the rollout of a Duchenne muscular dystrophy treatment.
  stat · 4mo ago
• STAT+: The biotech news you need to read today
  A Duchenne therapy lawsuit, FDA Commissioner Marty Makary’s White House troubles, and other news from The Readout
  stat · 4mo ago