REGENXBIO Inc. (RGNX): Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Johnson Fistel is investigating REGENXBIO (RGNX) for potential securities law violations after the FDA placed its RGX-121 gene therapy program on clinical hold due to MRI findings. The company does not expect to resubmit its application soon. Investors who suffered losses are encouraged to join the investigation.

Regenxbio's stock fell 25% to $8.05 after the FDA placed a clinical hold on its gene therapy candidate RGX-121 due to spinal nodules in five trial participants. The company halted near-term BLA resubmission plans for RGX-121 but will file a BLA for its Duchenne treatment this quarter and expects wet AMD trial results in Q4. According to the company, the nodules are likely benign, but the FDA required further review.

REGENXBIO (RGNX) announced an FDA clinical hold on RGX-121, its gene therapy for MPS II, due to asymptomatic spine MRI findings in five participants. The company does not expect to resubmit the BLA soon and will focus on other candidates. Investigators consider the findings likely benign and will continue monitoring. REGENXBIO plans to evaluate additional data and FDA feedback for next steps. MPS II is a rare genetic disorder affecting approximately 2,000 patients worldwide.

Regenxbio (RGNX) stock fell 24.3% to $8.12 after the FDA placed a clinical hold on its RGX-121 gene therapy due to safety concerns. The company delayed resubmitting the therapy's Biologics License Application. Analysts had recently downgraded the stock. The broader market showed minor declines, and peers were unaffected.

REGENXBIO Inc. (NASDAQ:RGNX) shares dropped 35% after the FDA placed a clinical hold on its gene therapy RGX-121 for MPS II due to asymptomatic spine MRI findings in five participants. The company does not expect to resubmit the BLA soon but remains focused on other candidates, including Duchenne and retinal disease treatments. REGENXBIO plans to submit a BLA for Duchenne this quarter and announce wet AMD data in Q4.

REGENXBIO (Nasdaq: RGNX) reported Q2 2026 results and pipeline updates. It said its Phase III AFFINITY DUCHENNE trial met its primary endpoint (p<0.0001) and it dosed the first patient in the Phase IIb/III NAAVIGATE diabetic retinopathy study. The FDA reaffirmed the path for RGX-121 BLA resubmission in Q3 2026. Cash was $105.5m at June 30, 2026, with pro forma ~$313m after July funding.