Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
AGIO Catalyst Timeline
Dated clinical, regulatory and corporate events for Agios Pharmaceuticals, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Agios Pharmaceuticals, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How AGIO actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-07-21 | tebapivat | Phase 2 topline data readout | Phase 2 |
Drug Pipeline Intelligence
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| PYRUKYND |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mitapivat Small moleculeNCT04770779 | Transfusion-dependent Alpha-Thalassemia | Phase 3 | ACTIVE NOT_RECRUITING | 312 | Jun 1, 2029 | ||||||
| Mitapivat Small moleculeNCT04770753 | Non-Transfusion-dependent Alpha-Thalassemia | Phase 3 | ACTIVE NOT_RECRUITING | 239 | Dec 1, 2028 | ||||||
| Mitapivat Small moleculeNCT05175105 | Pediatric Pyruvate Kinase Deficiency | Phase 3 | ACTIVE NOT_RECRUITING | 79 | Jan 1, 2030 | ||||||
| Mitapivat Small moleculeNCT05031780 | Sickle Cell Disease | NDA/BLA | ACTIVE NOT_RECRUITING | 445 | Feb 1, 2030 | ||||||
| AG-236 Small moleculeNCT07859423 | Polycythemia Vera | Phase 2 | NOT YET_RECRUITING | 245 | Aug 1, 2032 | ||||||
| Tebapivat Small moleculeNCT06924970 | Sickle Cell Disease | Phase 2 | ACTIVE NOT_RECRUITING | 59 | May 1, 2027 | ||||||
| Tebapivat Small moleculeNCT05490446 | Myelodysplastic Syndromes | Phase 2 | ACTIVE NOT_RECRUITING | 87 | Mar 1, 2029 | ||||||
| AG-181 Small moleculeNCT07241234 | Phenylketonuria | Phase 1 | RECRUITING | 20 | Jan 17, 2028 | ||||||
| AG-348 Small moleculeMarketedNCT03692052 | Thalassemia | Phase 2 | ACTIVE NOT_RECRUITING | 20 | Sep 30, 2030 | ||||||
| Mitapivat Small moleculeMarketedNCT03853798 | Pyruvate Kinase Deficiency | Phase 3 | COMPLETED | 90 | Jul 3, 2024 | ||||||
| Mitapivat Small moleculeMarketedNCT05610657 | Moderate Hepatic Impairment | Phase 1 | COMPLETED | 20 | Jul 21, 2023 | ||||||
| AG-946 Small moleculeCompletedNCT04536792 | Anemia, Sickle Cell | Phase 1 | COMPLETED | 122 | Dec 19, 2023 | ||||||
| AG-348 Small moleculeMarketedNCT02476916 | Pyruvate Kinase Deficiency | Phase 3 | COMPLETED | 159 | Apr 2, 2025 | ||||||
| AG-881 Small moleculeMarketedNCT02492737 | Acute Myeloid Leukemia (AML) | Phase 1 | COMPLETED | 46 | Mar 21, 2018 | ||||||
| AG-120 Small moleculeMarketedNCT03282513 | Hepatic Impairment | Phase 1 | COMPLETED | 33 | Mar 31, 2018 | ||||||
| ivosidenib Small moleculeMarketedNCT03071770 | Undisclosed | Phase 1 | COMPLETED | 60 | Sep 6, 2017 |
Clinical Trial Results
Readouts, endpoints and source filings for every AGIO program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| mitapivat PriorityAccelerated | sickle cell disease | Phase 3 | 2026-06-13 | significant improvement in hemoglobin response compared with placebo; clinically meaningful reduction in transfusion burden compared with placebo; patients in mitapivat arm who achieved hemoglobin response had clinically meaningful benefits across measures of sickle cell pain crises, fatigue, and other patient-reported outcomes; reduction in the annualized rate of sickle cell pain crises (SCPCs) compared with placebo; no overall difference between mitapivat and placebo for the key secondary endpoint measuring patient-reported fatigueRead More | Agios Showcases RISE UP Phase 3 Results at EHA 2026 Plenary Session Reinforcing Strong Anti-Hemolytic Profile of Mitapivat in Sickle Cell DiseaseRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Gheuens SarahOfficer (Chief Medical Officer) | Option | 7,866 62,511 held | $25.01 | 10/26/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in AGIO
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| PARKMAN HEALTHCARE PARTNERS LLC | 2.5 % (78.6 %) | 24.83 M | 669.05 K | 65.8% ( 265.52 K) |
AGIO Institutional Ownership Trends
AGIO Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How AGIO ranks across every disease it competes in
AGIO News
Agios to Host Third Quarter 2026 Financial Results Conference Call and Webcast on November 5 at 8:00 a.m. ET
Agios Pharmaceuticals will host a conference call and webcast on November 5, 2026, at 8:00 a.m. ET to discuss its third quarter 2026 financial results and business highlights. The event will be accessible via the company's website, with a replay available shortly after. Agios aims to redefine rare disease treatment through innovative medicines.
Read more →Agios Reports Second Quarter 2026 Financial Results and Provides Business Update
Agios Pharmaceuticals reported strong financial results for Q2 2026, with net revenues from mitapivat reaching $44.7 million, significantly up from the previous year. The company highlighted the successful U.S. launch of AQVESME for thalassemia and received FDA Priority Review for mitapivat in sickle cell disease. Agios also expanded its pipeline with the licensing of cevidoplenib for immune thrombocytopenia and plans to advance AG-236 into Phase 2/3 development.
Read more →Agios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell Disease
Agios Pharmaceuticals announced topline results from its Phase 2 trial of tebapivat in sickle cell disease. While hemoglobin response rates were consistent with the PK activator class, the trial did not demonstrate sufficient differentiation to support further development. Consequently, Agios will not advance tebapivat, focusing instead on mitapivat, which is under FDA Priority Review.
Read more →U.S. FDA Grants Priority Review to Agios’ sNDA for Mitapivat in Sickle Cell Disease
Agios Pharmaceuticals announced that the FDA has accepted its supplemental New Drug Application for mitapivat, an oral pyruvate kinase activator, in sickle cell disease, granting it Priority Review. If approved by the PDUFA goal date of November 1, 2026, mitapivat could be the first oral treatment for this condition. The application is supported by extensive clinical data from the RISE UP trials.
Read more →Agios to Host Second Quarter 2026 Financial Results Conference Call and Webcast on July 30 at 8:00 a.m. ET
Agios Pharmaceuticals will host a conference call and webcast on July 30, 2026, at 8:00 a.m. ET to discuss its second quarter financial results and business highlights. The event will be accessible via the company's website, with a replay available shortly after. Agios emphasizes its commitment to transforming rare disease treatment through innovative medicines.
Read more →Agios Showcases RISE UP Phase 3 Results at EHA 2026 Plenary Session Reinforcing Strong Anti-Hemolytic Profile of Mitapivat in Sickle Cell Disease
Agios Pharmaceuticals has presented promising results from the RISE UP Phase 3 trial of mitapivat for sickle cell disease at the EHA 2026 Congress. The trial demonstrated significant improvements in hemoglobin response and a notable reduction in transfusion dependency while remaining well-tolerated by patients. However, despite these positives, the primary endpoint for measuring pain crises did not achieve statistical significance. Overall, the data suggests a strong anti-hemolytic profile for mitapivat, highlighting its potential to enhance the quality of life for patients suffering from this condition.
Read more →Agios Enters Exclusive Global License Agreement with Oscotec to Develop and Commercialize Next-Generation SYK Inhibitor Cevidoplenib
Agios Pharmaceuticals has entered an exclusive global license agreement with Oscotec to develop cevidoplenib, a next-generation SYK inhibitor for immune thrombocytopenia (ITP). The agreement allows Agios to diversify its rare hematology portfolio and potentially achieve up to $1 billion in peak U.S. sales. Cevidoplenib aims to improve treatment outcomes for ITP patients, building on Phase 2 trial data that demonstrated durable platelet responses.
Read more →Agios Provides Update on Phase 2b Trial of Tebapivat in Lower-Risk Myelodysplastic Syndromes
Agios Pharmaceuticals announced that it will not advance tebapivat for lower-risk myelodysplastic syndromes (LR-MDS) after its Phase 2b trial failed to meet predefined efficacy thresholds. Although the drug was well tolerated and showed biological activity, it did not demonstrate sufficient clinical benefit. The company remains optimistic about tebapivat's potential in treating sickle cell disease, with further data expected later in 2026.
Read more →Agios’ PYRUKYND® (mitapivat) Approved in the European Union for Adults with Thalassemia
Agios Pharmaceuticals has received marketing authorization from the European Commission for PYRUKYND (mitapivat), the first medicine approved in the EU for adults with both transfusion-dependent and non-transfusion-dependent thalassemia. This approval is based on positive results from Phase 3 clinical trials, highlighting the drug's potential to improve patient outcomes. Agios will collaborate with Avanzanite Bioscience for distribution in Europe, further expanding access to this important treatment.
Read more →Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia
Agios has announced the approval of PYRUKYND® (mitapivat) in the European Union for adult patients with thalassaemia. This marks a significant milestone for Agios and its partner Avanzanite Bioscience. The approval is expected to enhance treatment options for patients suffering from this condition.
Read more →Agios Submits sNDA to FDA for U.S. Accelerated Approval of Mitapivat in Sickle Cell Disease
Agios Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the FDA for mitapivat, aiming for accelerated approval in treating sickle cell disease. The submission follows an agreement with the FDA on a confirmatory clinical trial, which will evaluate the drug's effectiveness in reducing transfusion burden. Mitapivat has shown promising results in previous trials, including improved hemoglobin levels and reductions in related complications. The outcomes from this confirmatory trial are crucial for translating accelerated approval into traditional approval.
Read more →Agios to Present New Data at EHA 2026 Reinforcing the Significant Therapeutic Impact of Mitapivat Across Multiple Rare Hemolytic Anemias
Agios Pharmaceuticals has announced that new data on mitapivat will be presented at EHA 2026, highlighting its significant therapeutic impact on multiple rare hemolytic anemias. Key presentations will include results from the RISE UP Phase 3 trial, which reported notable improvements in hemoglobin responses and reduced markers of hemolysis in patients with sickle cell disease. The company also plans to share long-term data showing sustained efficacy across various patient populations. This event marks a key opportunity for Agios to engage with the hematology community regarding advancements in treatment options.
Read more →Agios Reports First Quarter 2026 Financial Results and Provides Business Update
Agios Pharmaceuticals reported a strong first quarter for 2026, with net revenues from mitapivat reaching $20.7 million, a significant increase from the previous year. The company successfully launched AQVESME for thalassemia, with 242 prescriptions written. Agios plans to submit a supplemental New Drug Application for mitapivat in sickle cell disease in Q2 2026, marking a key growth opportunity.
Read more →Agios to Host First Quarter 2026 Financial Results Conference Call and Webcast on April 29 at 8:00 a.m. ET
Agios Pharmaceuticals will report its first quarter 2026 financial results on April 29 at 8:00 a.m. ET. The company plans to host a conference call and live webcast to discuss these business highlights. Investors can access the live event via the Investors section of the company website. A replay will be available online approximately two hours after the conclusion of the call.
Read more →Agios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDA
Agios Pharmaceuticals is advancing its oral pyruvate kinase activator, mitapivat, toward potential accelerated approval from the FDA for treating sickle cell disease. Following a pre-supplemental New Drug Application meeting, the company plans to submit a formal request for approval and is required to conduct a confirmatory clinical trial. The FDA's feedback emphasized the unmet need for treatment options in this condition, and Agios remains committed to expediting the approval process while ensuring rigorous standards are met.
Read more →Agios’ PYRUKYND® (mitapivat) Approved for Adults with Thalassemia in the United Arab Emirates
Agios Pharmaceuticals announced the approval of PYRUKYND (mitapivat) for adults with thalassemia in the UAE, marking it as the only treatment available for this condition in the region. The approval is based on successful Phase 3 trial results, highlighting the drug's potential to significantly improve patient outcomes. Agios, in partnership with NewBridge Pharmaceuticals, aims to enhance treatment access for thalassemia patients across the Gulf region.
Read more →Agios Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Agios Pharmaceuticals reported fourth-quarter net product revenue of $20.0 million and a full-year total of $54.0 million. The company announced FDA approval for AQVESME in thalassemia, marking its availability in the U.S. market. Agios holds $1.2 billion in cash and securities as of the end of 2025. The firm plans a pre-sNDA meeting with the FDA for mitapivat in sickle cell disease during the first quarter of 2026.
Read more →Agios to Host Fourth Quarter and Full Year 2025 Financial Results Conference Call and Webcast on February 12 at 8:00 a.m. ET
Agios Pharmaceuticals will host a conference call and webcast on February 12, 2026, to discuss its fourth quarter and full year 2025 financial results. The event will be accessible via the company's website, with a replay available shortly after. Agios emphasizes its commitment to transforming rare disease treatment through innovative medicines.
Read more →Agios Outlines 2026 Strategic Priorities and Key Milestones to Accelerate Rare Disease Portfolio Growth AQVESME (mitapivat) U.S. commercial launch in thalassemia underway following December 2025 FDA approval
Agios Pharmaceuticals has outlined its strategic priorities for 2026, focusing on the launch of AQVESME (mitapivat) in the U.S. for thalassemia following its FDA approval in December 2025. The company has detailed plans for expanding its rare disease portfolio, including upcoming trials for sickle cell disease and myelodysplastic syndromes. However, AQVESME poses risks of hepatocellular injury that require careful management and monitoring. Agios aims for significant growth, projecting over $1 billion in peak global sales from this launch and expansion of its early-stage pipeline.
Read more →Agios to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026
Agios Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. The company's management team is scheduled to speak at 8:15 a.m. PST. A live webcast will be available on their website, with a replay accessible for two weeks post-event.
Read more →