Every 10-Q that Agios Pharmaceuticals, Inc. (AGIO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-Q covers the quarterly report filed between annual reports, so if you follow AGIO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AGIO filings page.
Agios Pharmaceuticals reported much higher rare-disease drug revenue for the quarter ended June 30, 2026, mainly from AQVESME and PYRUKYND, while remaining loss-making. Net product revenue reached $44,745 for the quarter and $65,491 for the first half of 2026, compared with $12,455 and $21,181 a year earlier, with most growth from U.S. sales and rising rest-of-world contributions.
The company recorded a quarterly net loss of $100,703 and a six‑month net loss of $199,814, reflecting continued investment in R&D and commercialization. Operating expenses were $155,297 for the quarter, including $25,000 of in‑process R&D from a new global license for cevidoplenib from Oscotec. Cash, cash equivalents and marketable securities totaled $1.0 billion as of June 30, 2026, which management expects will fund current operations for at least twelve months.
Mitapivat remains the core asset, marketed as AQVESME in U.S. thalassemia and PYRUKYND in PK deficiency and other regions. A supplemental New Drug Application for sickle cell disease is under FDA priority review with a PDUFA goal date of November 1, 2026, supported by the ongoing REIGNITE phase 3 trial. Additional programs, including AG‑181 for phenylketonuria and AG‑236 for polycythemia vera, advanced through early clinical stages, while the Oscotec deal added cevidoplenib for immune thrombocytopenia and other autoimmune indications.
Agios Pharmaceuticals reported first-quarter 2026 product revenue of $20.7 million, up from $8.7 million a year earlier, driven by PYRUKYND® and the late-2025 U.S. launch of AQVESME™ for thalassemia and initial rest-of-world sales.
The company posted a net loss of $99.1 million, or $1.69 per share, as it increased research and development spending to $81.1 million and selling, general and administrative costs to $48.3 million to support its expanding rare-disease portfolio and commercialization.
Agios ended March 31, 2026 with $1.0 billion in cash, cash equivalents and marketable securities, and expects this to fund operations for at least 12 months while advancing mitapivat in thalassemia and sickle cell disease, tebapivat in lower-risk MDS and SCD, AG-181 in PKU, and AG-236 in polycythemia vera.
Agios Pharmaceuticals (AGIO) reported Q3 2025 results. Product revenue reached $12.9 million, up from $9.0 million a year ago, driven by PYRUKYND sales. Operating expenses included $86.8 million in research and development and $41.3 million in selling, general and administrative costs, leading to a net loss of $103.4 million for the quarter.
The company ended the period with $1.3 billion in cash, cash equivalents and marketable securities as of September 30, 2025. PYRUKYND advanced internationally: the Saudi Food and Drug Authority approved the thalassemia indication, and Europe’s CHMP issued a positive opinion. In the U.S., the FDA accepted the sNDA for thalassemia and set a PDUFA goal date of December 7, 2025 following a REMS submission.
For the first nine months of 2025, product revenue was $34.1 million versus $25.8 million in 2024, reflecting continued commercial execution while development spending supports the pipeline.
Agios Pharmaceuticals (AGIO) Q2-25 10-Q highlights:
- Revenue: PYRUKYND® sales rose 45% YoY to $12.5 m for the quarter and 26% YoY to $21.2 m YTD.
- Losses: Operating loss widened to $233.7 m YTD (-18%) as R&D spend climbed 13% to $164.7 m and SG&A 31% to $87.4 m. Net loss YTD was $201.3 m (-$3.49/sh) vs $177.7 m (-$3.14/sh) in 2024.
- Cash runway: Cash, cash equivalents and marketable securities total $1.31 bn (-$143 m from YE-24) after $188.6 m operating cash burn; management still projects ≥12-month liquidity.
- Balance sheet: Equity fell to $1.37 bn (-11%) on growing accumulated deficit (-$350 m). No debt reported.
- Clinical & regulatory: FDA accepted sNDA for PYRUKYND in α/β-thalassemia (PDUFA 7-Sep-25); EMA and GCC filings submitted. Phase 3 ENERGIZE & ENERGIZE-T met primary/secondary endpoints but revealed hepatocellular injury risk—monthly LFT monitoring now included in label & protocols.
- Pipeline spend: $10 m milestone paid to Alnylam for TMPRSS6 siRNA (AG-236). Phase 2/3 RISE-UP for SCD ongoing.
- Outlook: Company remains pre-profit; commercialization of PYRUKYND beyond PK-deficiency and retained earn-out on vorasidenib royalties are key value drivers.