Strong Revenue Growth
Delivered $20.7 million in net revenues in Q1 2026, representing 138% year‑over‑year growth; U.S. sales accounted for $18.8 million (≈90.8% of total) with $1.9 million ex‑U.S.
Successful U.S. Launch of AQVESME in Thalassemia
U.S. commercial launch executed with REMS fully operational end of January; 242 prescriptions written by REMS‑certified physicians as of March 31 (up from 44 as of Jan 31), early broad geographic and community prescriber adoption, smooth REMS onboarding and effective patient support driving strong initial demand.
Regulatory Progress for Mitapivat in Sickle Cell Disease
Completed pre‑sNDA meeting with FDA and plan to submit sNDA under the U.S. accelerated approval pathway in Q2 2026; formal/informal engagements progressed and confirmatory trial design aligned to operational feasibility and probability of success.
Robust Balance Sheet and Expense Discipline
Ended the quarter with over $1.0 billion in cash, cash equivalents and marketable securities; company expects 2026 operating expenses to be approximately flat versus 2025 (guidance of ~0% change) to support disciplined investment while maximizing portfolio value.
Pipeline and Upcoming Catalysts
Multiple near‑ and mid‑term catalysts: Phase IIb top line data for tebapivat in low‑risk MDS expected H1 2026 and Phase II sickle cell data H2 2026; Phase I healthy volunteer top line for AG‑236 in H1 and Phase Ib proof‑of‑mechanism for AG‑181 in PKU in H2; pediatric mitapivat trials (ENERGIZE‑KidsT and ENERGIZE‑Kids) planned/initiated.
Encouraging Early Tebapivat Signals
Tebapivat demonstrated a long half‑life (~87–93 hours) and pharmacodynamic durability, and showed a mean hemoglobin increase of 1.9 g/dL at the 5 mg once‑daily dose in early data, suggesting potential for meaningful clinical benefit.