BioSpace News Archive

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  Rare diseases

  REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval

  The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which is awaiting an FDA decision on or before Feb. 8.

  January 28, 2026

   · 

  2 min read

   · 

  Dan Samorodnitsky
• Press Releases

  Peritia Launches Platform to Accelerate Life Sciences, From Product Concept to Commercialization

  January 28, 2026

   · 

  1 min read