After Hunter Syndrome Setback, New Regenxbio Director Invests Nearly $1 Million
Newly appointed Regenxbio director Greg Ciongoli bought 102,603 shares for about $950,000 days after an FDA hold on Hunter syndrome therapy RGX-121.
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FDA Places Clinical Hold on REGENXBIO’s Gene Therapy for Hunter Syndrome
FDA places clinical hold on REGENXBIO’s RGX-121 for Hunter Syndrome after asymptomatic spine MRI findings in 5 patients. Patients remain well; no near-term BLA resubmission.
REGENXBIO Prices $100 Million Public Offering to Extend Cash Runway into 2028
Proceeds will support late-stage AAV gene therapy programs and extend cash runway to 2028.
FDA Aligns with REGENXBIO on Accelerated Approval Pathway for NAVSUNLI Gene Therapy in Hunter Syndrome
FDA reverses course and agrees to review existing data for NAVSUNLI gene therapy in Hunter syndrome.
REGENXBIO Q1 Earnings: Revenue Miss Overshadows Positive Duchenne Gene Therapy Data
Regenxbio’s DMD gene therapy showed strong results, boosting muscle protein and safety, moving closer to FDA approval.
uniQure Stock Tanks on FDA Comments – But Is It Really About AMT-130?
uniQure shares fell about 33% after FDA Commissioner Marty Makary's comments on rare disease drugs. But analysts say his remarks likely targeted another therapy, not uniQure's AMT-130 for Huntington's disease.