as of 11-10-2026 1:34pm EST
Agios Pharmaceuticals Inc is a biopharmaceutical company focused on the field of cellular metabolism to create differentiated medicines for rare diseases, with a focus on classical hematology. The company's primary focus is to develop potentially transformative small-molecule medicines. Its product candidate, Pyrukynd (mitapivat), is an activator of both wild-type and mutant pyruvate kinase enzymes, developed for the treatment of hemolytic anemias. The other drug candidates in its pipeline include Tebapivat (PK activator), being developed as a potential treatment for MDS-associated anemia and sickle cell disease, AG-181 (PAH stabilizer), AG-236 and others.
| Founded: | 2007 | Country: | United States |
| Employees: | N/A | City: | CAMBRIDGE |
| Market Cap: | 2.2B | IPO Year: | 2013 |
| Target Price: | $46.11 | AVG Volume (30 days): | 1.2M |
| Analyst Decision: | Buy | Number of Analysts: | 10 |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -4.46 | EPS Growth: | -161.17 |
| 52 Week Low/High: | $22.24 - $46.00 | Next Earning Date: | 11-05-2026 |
| Revenue: | $43,011,000 | Revenue Growth: | N/A |
| Revenue Growth (this year): | 227.92% | Revenue Growth (next year): | 96.10% |
| P/E Ratio: | -7.01 | Index: | |
| Free Cash Flow: | -377293000.0 | FCF Growth: | N/A |
Chief Medical Officer
Avg Cost/Share
$37.69
Shares
7,866
Total Value
$296,469.54
Owned After
54,645
SEC Form 4
Chief Medical Officer
Avg Cost/Share
$37.52
Shares
500
Total Value
$18,760.00
Owned After
54,645
SEC Form 4
Chief Medical Officer
Avg Cost/Share
$37.53
Shares
1,489
Total Value
$55,882.17
Owned After
54,645
SEC Form 4
| Insider | Ticker | Relationship | Date | Transaction | Avg Cost | Shares | Total Value | Owned After | SEC Forms |
|---|---|---|---|---|---|---|---|---|---|
| Gheuens Sarah | AGIO | Chief Medical Officer | Oct 26, 2026 | Sell | $37.69 | 7,866 | $296,469.54 | 54,645 | |
| Gheuens Sarah | AGIO | Chief Medical Officer | Oct 22, 2026 | Sell | $37.52 | 500 | $18,760.00 | 54,645 | |
| Gheuens Sarah | AGIO | Chief Medical Officer | Oct 21, 2026 | Sell | $37.53 | 1,489 | $55,882.17 | 54,645 |
SEC 8-K filings with transcript text
Nov 5, 2026 · 100% conf.
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2 agio-110526xfyxex991earnin.htm
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Exhibit 99.1
Agios Reports Third Quarter 2026 Financial Results and Provides Business Update
•Mitapivat (PYRUKYND® and AQVESME®) delivered worldwide net revenues of $55.4 million in third quarter of 2026, more than four times the $12.9 million reported in third quarter of 2025
•Strong U.S. demand for AQVESME in thalassemia continues, with 619 cumulative prescriptions with completed start forms from REMS-certified physicians, plus 48 additional prescriptions with start forms in process as of September 30, 2026
•New PDUFA goal date for mitapivat sickle cell disease sNDA set for February 1, 2027; company is launch-ready and in labeling discussions with FDA
•14 abstracts accepted at ASH 2026, including new clinical data for mitapivat in sickle cell disease and for AG-236 in polycythemia vera, highlighting the breadth and depth of Agios’ rare hematology portfolio
•$907.0 million in cash, cash equivalents, and marketable securities as of September 30, 2026, fully funding commercial launches and pipeline programs; company is targeting non-GAAP profitability in 2028
CAMBRIDGE, Mass., Nov. 5, 2026 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced financial results and updates for the third quarter ended September 30, 2026.
“The third quarter was a record for our product revenue, outperforming our entire 2025 total in just three months. This growth was driven by the U.S. commercial launch of AQVESME in thalassemia, where broadening demand is translating into a durable base of patients on therapy,” said Brian Goff, Chief Executive Officer, Agios. “This launch has built the commercial foundation for our largest indication opportunity with mitapivat – sickle cell disease. Our conviction in mitapivat for patients with sickle cell disease is grounded in the robust efficacy and safety data generated to date and we are launch-ready ahead of our PDUFA goal date of February 1, 2027. With this commercial infrastructure, alongside a strong balance sheet and a disciplined operating model, Agios is well positioned for sustained growth as a focused, rare hematology company.”
Third Quarter 2026 and Recent Corporate Highlights
•Mitapivat (PYRUKYND® and AQVESME®) Commercial Performance and Update –
o$48.7 million in U.S. net revenue and $6.6 million in ex-U.S. net revenue in the third quarter of 2026
•U.S. net revenue increased 20% sequentially, driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026.
•Ex-U.S. net revenue increased 74% sequentially, driven primarily by early access programs in Europe following the late May 2026 approval of PYRUKYND (mitapivat) in thalassemia in the European Union. This robust, early momentum underscores the strong global opportunity for mitapivat, which the company is advancing through capital-efficient partnerships with Avanzanite Bioscience B.V. in Europe and NewBridge Pharmaceuticals in the Gulf Cooperation Council (GCC) region.
oAQVESME demand continues to expand following the January 2026 U.S. commercial launch in thalassemia
•In the third quarter, 177 AQVESME prescriptions with completed Agios start forms (ASFs) were written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians, bringing cumulative prescriptions to 619 as of September 30, 2026.
•An additional 48 cumulative prescriptions had ASFs in process as of September 30, 2026, which are not included in the reported metric above.
•Demand continues to broaden, with deeper penetration in transfusion-dependent patients and expansion into the larger non-transfusion dependent population. Approximately 75% of patients remain on AQVESME after six months of treatment.
•Operating Model Update –
oOver the course of 2026, Agios reviewed its operating model, and will have reduced its R&D headcount by over 100 roles by year-end, representing a more than 35% decrease compared with 2025. The company expects the associated cost savings of these reductions to be realized in 2027.
Research and Development (R&D) Highlights
•Mitapivat (pyruvate kinase [PK] activator) –
oSickle Cell Disease –
•Agios announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its mitapivat sickle cell disease supplemental New Drug Application (sNDA) by three months, from November 1, 2026, to February 1, 2027.
•The FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease. The FDA classified Agios’ response to this information request as a major amendment to the sNDA, resulting in the three-month review extension.
•Agios will continue its labeling discussions with the FDA as part of the ongoing sNDA review, including elements of a potential REMS.
•American Society of Hemat
Jul 30, 2026 · 99% conf.
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Apr 29, 2026 · 100% conf.
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$27.18
Act: +8.45%
2 agio-42926xfyxex991earning.htm
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Agios Reports First Quarter 2026 Financial Results and Provides Business Update
•Mitapivat (PYRUKYND® and AQVESME™) generated worldwide net revenues of $20.7 million in the first quarter of 2026, compared to $8.7 million in the first quarter of 2025
•Strong initial U.S. commercial launch of AQVESME in thalassemia, with 242 prescriptions written as of March 31, 2026
•Company plans to submit mitapivat sNDA for sickle cell disease in the second quarter of 2026
•Pipeline advancing to multiple value-driving inflection points in 2026, including two Phase 2 readouts for next-generation PK activator tebapivat
•$1.0 billion in cash, cash equivalents, and marketable securities as of March 31, 2026
CAMBRIDGE, Mass., Apr. 29, 2026 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced financial results and updates for the first quarter ended March 31, 2026.
“Our first-quarter performance reflects strong execution and significant progress against our 2026 strategic objectives,” said Brian Goff, Chief Executive Officer, Agios. “The solid early momentum of our U.S. commercial launch of AQVESME in thalassemia highlights both the medicine’s clinical value and strong community reception. Additionally, following collaborative engagement with the FDA, we now plan to submit our mitapivat sNDA for sickle cell disease under the U.S. accelerated approval pathway in the second quarter. 2026 marks an important growth inflection point for Agios as we continue to build a sustainable rare disease company that is rooted in hematology and focused on delivering differentiated medicines that create meaningful long-term value for patients and shareholders.”
First Quarter 2026 and Recent Corporate Highlights
Mitapivat (PYRUKYND® and AQVESME™) Commercial Performance and Update
•$18.8 million in U.S. net revenue and $1.9 million in ex-U.S. net revenue in the first quarter of 2026.
oU.S. net revenue was driven by the U.S. commercial launch of AQVESME™ (mitapivat) in thalassemia in late January 2026.
oEx-U.S. net revenue reflected demand for PYRUKYND® (mitapivat) in thalassemia in Saudi Arabia.
•242 AQVESME mitapivat prescriptions for thalassemia were written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians as of March 31, 2026, driven by motivated prescribers and highly engaged patients.
R&D Highlights
•Mitapivat
oThalassemia –
In March 2026, the Emirates Drug Establishment of the United Arab Emirates (UAE) approved PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. With this approval, PYRUKYND becomes the only medicine approved in the UAE for this broad patient population.
Mitapivat is now approved for adults with thalassemia in the U.S., Saudi Arabia, and the UAE. A marketing application for mitapivat in thalassemia is currently under review by the European Commission.
oSickle Cell Disease –
Agios confirmed plans to pursue U.S. accelerated approval for mitapivat in sickle cell disease, following completion of its pre-supplemental New Drug Application (sNDA) meeting with the U.S. Food and Drug Administration (FDA).
The FDA’s accelerated approval pathway expedites the availability of medicines that can fill a medical need for a serious condition, with the requirement of a confirmatory clinical trial to convert to a traditional approval.
The company now plans to submit an sNDA for mitapivat in sickle cell disease in the second quarter of 2026.
•Tebapivat
oLower-Risk Myelodysplastic Syndromes (LR-MDS) –
Agios expects to report topline results from its Phase 2b trial in the first half of 2026. Based on findings from the Phase 2a trial, the Phase 2b open-label trial is evaluating three higher daily dose levels of tebapivat (10 mg, 15 mg, and 20 mg) over a 24-week period. The primary endpoint is the proportion of participants achieving transfusion independence, defined as being transfusion-free for at least 8 consecutive weeks during the 24-week period.
oSickle Cell Disease –
Agios expects to report topline results from its Phase 2 trial in the second half of 2026. This double-blind, randomized, placebo-controlled trial is evaluating three daily dose levels of tebapivat (2.5 mg, 5 mg, and 7.5 mg) versus matched placebo over a 12-week period. The primary endpoint is hemoglobin response, defined as a ≥1.0 g/dL increase in average
hemoglobin concentration from Week 10 through Week 12 compared with baseline.
First Quarter 2026 Financial Results
For the quarter ended March 31, 2026, net loss was $99.1 million, compared to net loss of $89.3 million for the quarter ended March 31, 2025.
•Net product revenue from U.S. sales of mitapivat (PYRUKYND and AQVESME) for the first quarter of 2026 was $18.8 million, compared to $8.7 million for th
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