The firms’ one-time hemophilia B gene therapy has been approved in the EU just months after a US nod, but concerns remain about its prospects on a market that has seen several setbacks for other gene therapies.

Pfizer’s fidanacogene elaparvovec has hit the mark in a Phase III hemophilia B trial just a month after rival UniQure’s Hemgenix won US approval, with Pfizer’s plans for regulatory action raising the stakes for Hemgenix.

Freeline Therapeutics and Kriya are taking divergent paths to success amid market doldrums, as the former divests and pulls back on investment, while the latter bulks up its pipeline through an acquisition.

Industry investors foresee continued hardship for public companies still without compelling clinical data for their assets, plus the growing influence of the US Inflation Reduction Act on biopharma strategy.