US Pharma MarketingRegenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues
Regenxbio plans to resubmit its Hunter syndrome gene therapy RGX-121 after the FDA reversed course, saying existing data are sufficient for accelerated approval review. Topic Hubs AI drug discovery: News, analysis and interviews Antibody-drug conjugates: The next wave of targeted cancer drugs Biopharma M&A and dealmaking: Who’s buying and why Biopharma people moves: CEO changes, executive hires, board positions Biotech IPOs: Tracking the market for new public offerings Biotech venture funding: Who’s raising and where the money is going Cell and gene therapy manufacturing: Scaling the next frontier China biotech: Licensing deals and the Biosecure Act CRISPR and gene editing:…
Regenxbio said that it plans to resubmit its Hunter syndrome gene therapy following another apparent walk back by the FDA after leadership departures.
According to Regenxbio, the FDA told the biotech that its existing data ...
Source: Endpoints News