STAT+: Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field

STAT PlusBiotech Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field Agency’s rejection rate for cell and gene therapies doubled since 2024 Manage alerts for this article Email this article Share this article By Andrew JosephMay 6, 2026 Europe Correspondent Andrew Joseph[email protected]Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71. ROME — When Tim Hunt, who leads an organization for cell and gene therapy makers, reached for some reasons for optimism for the jittery field at a conference here last week, he highlighted the recent approvals of rare disease treatments from the likes of Rocket Pharmaceuticals and Regeneron Pharmaceuticals.

There was one other headline he touted as potentially promising: “FDA vaccine chief to leave the agency again.”Advertisement The allusion to Vinay Prasad — the Food and Drug Administration’s top regulator of gene and cell therapies as well as vaccines until his departure from the agency last week — was an indication that even at this event, designed to emphasize the opportunities and roadblocks the sector faces in Europe, it couldn’t escape the decisions that are coming from 4,500 miles away. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%!

2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In drug development, FDA, Policy, rare disease, STAT+ Submit a correction requestReprints Andrew Joseph Europe Correspondent Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71.

Newsletter Understand how science, health policy, and medicine shape the world every day Recommended The Readout May 7, 2026 STAT Plus: FDA revisits a rare cancer treatment it rejected a few months ago Biotech May 7, 2026 STAT Plus: FDA to reconsider treatment for rare cancer after its surprise rejection Advertisement Biotech May 7, 2026 STAT Plus: Next-gen Duchenne drug from Entrada disappoints Adam's Biotech Scorecard May 7, 2026 STAT Plus: Color me skeptical: Drinking gold is not an ALS cure Biotech May 7, 2026 STAT Plus: Angelini Pharma buys Catalyst Pharmaceuticals and its rare disease drugs for $4.1B Subscriber Picks