The earnings call reflects a positive sentiment with strong financial performance, global regulatory progress, and significant pipeline advancements. However, there are challenges with increased expenses and potential regulatory hurdles related to the REMS program.
Company Guidance
During the Agios Pharmaceuticals third-quarter 2025 conference call, significant guidance was provided, highlighting multiple upcoming catalysts and financial metrics. The company is anticipating a PDUFA date for PYRUKYND (a PK activator) for thalassemia on December 7, following the FDA's request for a REMS program, and expects top-line results from the RISE UP Phase III trial for sickle cell disease by year-end. The third quarter saw $12.9 million in net revenue for PYRUKYND, marking a 44% year-over-year increase. The company maintains a strong financial position with approximately $1.3 billion in cash and investments, positioning them to support potential U.S. launches and advance their rare disease pipeline. Additionally, they achieved enrollment completion in the Phase IIb trial of Tebapivat for lower-risk myelodysplastic syndromes. The team has focused on building a capital-efficient global commercial model and is actively engaging with the thalassemia and sickle cell communities to ensure a successful launch, while continuing to explore strategic business development opportunities to expand their pipeline.
PYRUKYND Revenue Growth
Third quarter net PYRUKYND revenue was $12.9 million, an increase of 44% compared to the third quarter of 2024 and a 3% increase compared to the second quarter of 2025.
Global Regulatory Approvals
PYRUKYND received approval for adults with thalassemia in Saudi Arabia and a positive CHMP opinion recommending marketing authorization in Europe for thalassemia treatment.
Strong Financial Position
Agios maintains a strong balance sheet with approximately $1.3 billion in cash and investments, enabling strategic investments in pipeline growth and potential U.S. launches.
Pipeline Progress
Enrollment completed for the Phase IIb trial of Tebapivat in lower-risk MDS, with top line data expected early next year. Progress continues in early-stage programs AG-181 for phenylketonuria and AG-236 for polycythemia vera.
Agios Pharma (AGIO) Earnings, Revenues Date & History
The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
AGIO Earnings-Related Price Changes
Report Date
Price 1 Day Before
Price 1 Day After
Percentage Change
Oct 30, 2025
$41.96
$43.18
+2.91%
Jul 31, 2025
$37.54
$37.22
-0.85%
May 01, 2025
$29.69
$30.94
+4.21%
Feb 13, 2025
$32.81
$33.30
+1.49%
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Agios Pharma (AGIO) report earnings?
Agios Pharma (AGIO) is schdueled to report earning on Feb 12, 2026, TBA (Confirmed).
What is Agios Pharma (AGIO) earnings time?
Agios Pharma (AGIO) earnings time is at Feb 12, 2026, TBA (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.