REGENXBIO Navigates FDA Setbacks, Advances Key Pipelines

Biotech firm cautiously optimistic after recent regulatory hurdles for AMD and Duchenne treatments

Published on Feb. 13, 2026

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Regenxbio, a biotechnology company, is navigating recent FDA program setbacks as it advances its RGX-314 and RGX-202 pipelines for the treatment of age-related macular degeneration (AMD) and Duchenne muscular dystrophy (DMD). Despite the regulatory challenges, the company remains cautiously optimistic about the potential of its gene therapy candidates.

Why it matters

Regenxbio's ability to successfully navigate the FDA approval process for its key pipeline products is crucial for the company's long-term growth and the availability of new treatment options for patients with AMD and DMD, two debilitating conditions.

The details

Regenxbio has faced recent setbacks with the FDA regarding its RGX-314 program for AMD and RGX-202 for DMD. However, the company is continuing to advance these pipeline candidates and remains cautiously optimistic about their potential. The company is working closely with the FDA to address the regulatory concerns and move the programs forward.

  • Regenxbio received the FDA setbacks in 2026.
  • The company is currently working to address the regulatory issues and continue advancing its key pipeline products.

The players

Regenxbio

A biotechnology company focused on developing gene therapy treatments for various diseases, including age-related macular degeneration and Duchenne muscular dystrophy.

RGX-314

Regenxbio's gene therapy candidate for the treatment of age-related macular degeneration.

RGX-202

Regenxbio's gene therapy candidate for the treatment of Duchenne muscular dystrophy.

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What they’re saying

“We must continue to work closely with the FDA to address their concerns and move our key pipeline products forward.”

— Myriam Hernandez Alvarez, Author (Seeking Alpha)

What’s next

Regenxbio plans to provide updates on its discussions with the FDA and the progress of its RGX-314 and RGX-202 programs in the coming months.

The takeaway

Regenxbio's ability to navigate the regulatory challenges and advance its promising gene therapy candidates for AMD and DMD will be crucial for the company's long-term success and the availability of new treatment options for patients with these debilitating conditions.