US FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval bid
- Posted on June 22, 2026
- By Bing News
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US FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval bid
June 22 (Reuters) - Regenxbio said on Monday that the U.S. FDA had indicated it would reverse the earlier rejection of the company's rare-disease gene therapy, and that existing data would be sufficient to support an accelerated approval application. Shares of the Rockville, Maryland-based drug developer were up 10% in premarket trading. In February, the U.S. Food and Drug Administration
