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Mar 31, 2023
Agios Q1 2023 Earnings Report
Agios reported first quarter 2023 financial results and business highlights.
Key Takeaways
Agios reported U.S. PYRUKYND® net revenue of $5.6 million in Q1 and had $1.0 billion of cash, cash equivalents and marketable securities as of March 31, 2023. The company closed screening of the Phase 3 studies of PYRUKYND® in thalassemia and expects data readout of the Phase 2 portion of the RISE UP study of PYRUKYND® in sickle cell disease in the middle of this year.
PYRUKYND® U.S. net revenue was $5.6 million in Q1 2023.
127 unique patients have completed prescription enrollment forms, representing an increase of 21 percent over the fourth quarter of 2022.
89 patients are on PYRUKYND® therapy, representing a 14 percent increase over the fourth quarter of 2022.
Screening closed for the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND® in thalassemia.
Forward Guidance
Agios expects that its cash, cash equivalents and marketable securities together with anticipated product revenue and interest income will enable the company to execute its operating plan, including funding the currently planned development programs for mitapivat, AG-946 and PAH stabilization and commercializing mitapivat outside of the U.S. through one or more partnerships.
Positive Outlook
- Complete enrollment of the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND® in not regularly transfused and regularly transfused adults with thalassemia, respectively, by mid-year.
- Announce data readout from the Phase 2 portion of the RISE UP study of PYRUKYND® and go/no-go to Phase 3 decision by mid-year.
- Enroll more than half of patients in the Phase 3 ACTIVATE-kids and ACTIVATE-kidsT studies of PYRUKYND® by year-end.
- Complete enrollment of the Phase 2a study of novel PK activator AG-946 by year-end.
- File investigational new drug (IND) application for phenylalanine hydroxylase (PAH) stabilizer for the treatment of phenylketonuria (PKU) by year-end.
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