GlobeNewswire·Apr 29, 2026, 6:30 AM ET

Agios Reports First Quarter 2026 Financial Results and Provides Business Update

AGIO

Mitapivat (PYRUKYND ® & AQVESME™) generated $20.7 million in worldwide net revenues in Q1 2026, up from $8.7 million in Q1 2025.
U.S. net revenue reached $18.8 million driven by the January 2026 launch of AQVESME in thalassemia, while ex-U.S. revenue was $1.9 million.
242 AQVESME prescriptions for thalassemia were written by REMS-certified U.S. physicians as of March 31, 2026.
Agios plans to submit a supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease in Q2 2026 under the FDA accelerated approval pathway.
PYRUKYND received approval in the UAE in March 2026 for adult thalassemia patients, marking its third major approval alongside the U.S. & Saudi Arabia.
A marketing application for mitapivat in thalassemia is currently under review by the European Commission.
Topline results from the Phase 2b trial of tebapivat for lower-risk myelodysplastic syndromes (LR-MDS) are expected in the first half of 2026.
Topline results from the Phase 2 trial of tebapivat for sickle cell disease are expected in the second half of 2026.
Agios reported a net loss of $99.1 million for Q1 2026, compared to $89.3 million in the same period last year.
Research & Development expenses were $81.1 million in Q1 2026, while Selling, General & Administrative expenses were $48.3 million.
Cash, cash equivalents, & marketable securities totaled $1.0 billion as of March 31, 2026.
The company expects its financial position to support the U.S. commercial launch of AQVESME, potential sickle cell disease launch, clinical program advancement, & pipeline expansion.