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Mar 31, 2022
Agios Q1 2022 Earnings Report
Agios reported first U.S. revenue from PYRUKYND® and continued clinical trials.
Key Takeaways
Agios Pharmaceuticals reported $0.8 million in net U.S. product revenue from PYRUKYND® in the first quarter of 2022, following FDA approval in February. The company is advancing clinical trials for PYRUKYND® in other indications and progressing its PK activation portfolio with AG-946.
Received U.S. FDA Approval for PYRUKYND® for hemolytic anemia in adults with Pyruvate Kinase (PK) deficiency.
Launched PYRUKYND® in the U.S. and generated approximately $0.8 million in net revenue for the first partial quarter.
Pivotal studies for PYRUKYND® in Thalassemia and Sickle Cell Disease are open and enrolling.
Completed healthy volunteer cohorts and initiated the sickle cell disease cohort of AG-946 Phase 1 study.
Forward Guidance
Agios anticipates several key milestones in 2022, including regulatory decisions and the initiation/enrollment of patients in Phase 3 and Phase 2 studies.
Positive Outlook
- Receive European Medicines Agency (EMA) regulatory decision for PYRUKYND® in adults with PK deficiency by year-end.
- Initiate Phase 3 ACTIVATE-kids and ACTIVATE-kidsT studies of PYRUKYND® in pediatric patients with PK deficiency in mid-2022.
- Enroll a meaningful portion of patients in the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND® in adults with thalassemia by year-end.
- Complete enrollment in the Phase 2 portion of the RISE UP study of PYRUKYND® in sickle cell disease by year-end.
- Initiate Phase 2a study of AG-946 in adults with low- to intermediate-risk MDS by year-end.
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