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Biotech ETFs Rally as FDA Signals More Flexible Drug Approval Pathway
Biotech exchange-traded funds have posted strong gains in the first half of 2026, led by a 17.9% rise in the State Street SPDR S&P Biotech ETF as of June 17, as the FDA signaled a more flexible approach toward approving treatments for serious diseases. The shift fueled a nearly 78% surge in UniQure shares after the agency allowed the company to refile its Huntington's disease gene therapy application using three-year clinical trial data, reversing an earlier position that Phase 1 and Phase 2 data would not support accelerated approval. The FDA also opened new approval pathways for Atara Biotherapeutics and Replimune, and released favorable briefing documents for Moderna's flu vaccine ahead of an advisory committee meeting. Other biotech ETFs have also benefited, with the ARK Genomic Revolution ETF up about 20%, the iShares Genomics Immunology and Healthcare ETF up 14.5%, the Virtus Biotech Clinical Trials ETF up 11.6%, and the Global X Genomics & Biotechnology ETF up 10% year-to-date. The more supportive regulatory environment, which follows leadership changes at the FDA, comes alongside continued M&A activity including Merck's acquisition of Terns Pharmaceuticals and Novartis' purchase of Avidity Biosciences.
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QURE · Regulation · Positive FDA allowed UniQure to refile its Huntington's disease gene therapy application using three-year clinical trial data, reversing earlier position.
ATRA · Regulation · Positive FDA opened new approval pathways for Atara Biotherapeutics.
REPL · Regulation · Positive FDA opened new approval pathways for Replimune.
MRNA · Regulation · Positive FDA released favorable briefing documents for Moderna's flu vaccine ahead of advisory committee meeting.
MRK · Capital · Neutral Merck's acquisition of Terns Pharmaceuticals is mentioned as part of M&A activity, but no direct impact on Merck.