uniQure (QURE) Q3 2026 earnings summary

Executive summary

• FDA accepted the AMT-130 BLA for Priority Review under the Accelerated Approval pathway, with a May 1, 2027 PDUFA target; the U.K. MHRA validated the MAA.

• September 30 liquidity was $768.4M in cash, cash equivalents and investment securities, or $770.0M including restricted cash; projected operations are expected to be funded into 2030.

Financial highlights

• Q3 revenue was $5.2M vs. $3.7M; 9M revenue was $14.6M vs. $10.5M, primarily from license royalties on HEMGENIX® sales.

• Q3 R&D was $35.5M vs. $34.4M and SG&A was $23.9M vs. $19.4M; 9M R&D was $98.7M vs. $105.9M and SG&A was $61.4M vs. $43.8M.

• Q3 net loss narrowed to $61.2M from $80.5M, or $0.88 vs. $1.38 per share; 9M net loss widened to $195.8M from $161.9M.

• Q3 operating loss was $53.0M vs. $51.0M; 9M operating loss was $150.9M vs. $134.2M.

• Higher personnel, professional fees and IT costs supported commercial readiness; 9M operating cash use was $114.6M vs. $100.4M.

Outlook and guidance

• AMT-130 confirmatory-study screening is targeted by year-end 2026; the global study plans ~200 patients randomized 2:1 to high-dose AMT-130 or standard of care, with TFC at 36 months as the primary endpoint.

• Updated AMT-260 and AMT-191 data are expected in H1 2027; the core commercial team is expected to be in place by early 2027.

• Field medical, market access and strategic account teams are being built ahead of a potential AMT-130 launch; no specific SG&A guidance was given, with spending expected to rise under a disciplined approach.