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Sep 30, 2023
Agios Q3 2023 Earnings Report
Agios reported its Q3 2023 financial results and business highlights.
Key Takeaways
Agios Pharmaceuticals reported Q3 2023 U.S. net product revenue from PYRUKYND® sales of $7.4 million, a 10% increase over Q2 2023. The company's cash, cash equivalents, and marketable securities totaled $872.4 million as of September 30, 2023. They anticipate multiple data readouts by the end of next year.
PYRUKYND® U.S. net revenue was $7.4 million in Q3 2023, a 10% increase over the second quarter of 2023.
First patient dosed in the Phase 3 portion of the RISE UP pivotal study of mitapivat in sickle cell disease.
Completed enrollment in the Phase 3 ACTIVATE-KidsT pediatric study of mitapivat in PK Deficiency.
On track for data readouts in two Phase 3 trials of mitapivat in thalassemia next year and topline data for AG-946 in LR-MDS by year-end 2023.
Forward Guidance
Agios expects that its cash, cash equivalents and marketable securities together with anticipated product revenue, interest income and vorasidenib milestone will enable the company to fund its operating expenses and capital expenditures at least into 2026.
Positive Outlook
- Present data from the positive Phase 2 portion of the RISE UP study of mitapivat at an upcoming medical meeting.
- Advance patient enrollment in the Phase 3 portion of RISE UP.
- Announce topline data from the Phase 2a study of novel PK activator AG-946 by year-end 2023.
- Announce topline data from the two Phase 3 studies of mitapivat in non-transfusion-dependent and transfusion-dependent thalassemia in the first and second halves of 2024, respectively.
- Complete enrollment in the Phase 3 ACTIVATE-kids study of mitapivat in non-regularly transfused pediatric PK deficiency next year.
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