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Agios Pharmaceuticals, Inc.

AGIO
Richly ValuedPharma · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$31.81
▼ -0.11 · -0.34%

Financials

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52W LOW $22.2452W HIGH $46.00
Volume
835.68 K
Value Traded
34.92 M
Short % Float
12.97%
+1.79%Week
-5.44%1 Month
-21.55%3 Month
-4.04%6 Month
-50.85%5 Year
-2.97%All Time

Cash Data

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Key Stats

Market Cap
1.90 B
EPS (TTM)
-6.89
P/E Ratio
-
Ent. Value
934.29 M
Total Shares
59.71 M
Float Shares
58.25 M
Insiders
2.42%
Institutions
113.55%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA Date
mitapivat (PYRUKYND® / AQVESME™)
sickle cell disease
PriorityAccelerated
PDUFASmall MoleculesHematologic System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

AGIO Catalyst Timeline

Dated clinical, regulatory and corporate events for Agios Pharmaceuticals, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Agios Pharmaceuticals, Inc.

1073Total events
9Upcoming
208Tier-1 (high impact)
2014 to 2028Coverage

Upcoming catalysts 2

T2sNDA Submission
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MitapivatApproved
T1Primary Endpoint Met
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AG-181

Event history 50

▲Oral PresentationMitapivatApprovedPresentation
Presentation of RISE UP Phase 3 results at EHA 2026 Plenary Session
sickle cell diseasesource ↗
●R&D DayPresentation
Investor conference call and webcast to discuss EHA 2026 data
◆Poster PresentationMitapivatApprovedPresentation
Poster on metabolic profile of Diamond-Blackfan anemia syndrome erythroid progenitors
Diamond-Blackfan anemia syndromesource ↗
◆Quarterly UpdateCorporate
Agios investor conference call and webcast during EHA 2026
◆Full ResultsMitapivatApprovedClinical Data
Detailed efficacy and safety data from RISE UP Phase 3 trial presented at EHA 2026
sickle cell diseasesource ↗
◆Long Term DataMitapivatApprovedClinical Data
Long-term data from ENERGIZE open-label extension showing durability up to 127 weeks
non-transfusion-dependent alpha- or beta-thalassemiasource ↗
◆Poster PresentationMitapivatApprovedPresentation
Poster on subgroup analysis of ENERGIZE in patients with baseline hemoglobin ≥9.5 g/dL
non-transfusion-dependent alpha- or beta-thalassemiasource ↗
◆Subgroup AnalysisMitapivatApprovedClinical Data
Subgroup analysis of ENERGIZE in patients with baseline hemoglobin ≥9.5 g/dL
non-transfusion-dependent alpha- or beta-thalassemiasource ↗
◆Oral PresentationMitapivatApprovedPresentation
Oral presentation of SATISFY Phase 2 trial results at EHA 2026
hereditary spherocytosis, hereditary xerocytosis, congenital dyserythropoietic anemia type IIsource ↗
◆Long Term DataMitapivatApprovedClinical Data
56-week follow-up results from SATISFY study on iron burden and spleen size
hereditary spherocytosis, hereditary xerocytosis, congenital dyserythropoietic anemia type IIsource ↗
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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 %
2026-06-30AG-236 Phase 1 topline data readout Phase 1
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C50 / 100
Pipeline Score
$313M
Pipeline Value
$233M
Commercial Value
Richly Valued
Valuation Signal
5
Drugs Scored
0.2x
rNPV / MCap
Top 17%
Micro Cap
(rank 113 of 660)
Percentile Rank
Agios Pharmaceuticals, Inc. carries a moderate pipeline score (50/100), with $782M risk-adjusted pipeline value, led by AG-236 in Polycythemia Vera (Phase 2).
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q)) Revenue $98.3M x 2.4 = $233M
ProductRevenuePrior periodChange
PYRUKYND$98M$41M+140.6%
Showing 1 of 5 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
AG-236 Small moleculeNCT07859423Polycythemia VeraPhase 2 NOT YET_RECRUITING 245Aug 1, 2032
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Clinical Trial Results

Readouts, endpoints and source filings for every AGIO program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
mitapivat
PriorityAccelerated
sickle cell diseasePhase 32026-06-13significant 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 MoreAgios Showcases RISE UP Phase 3 Results at EHA 2026 Plenary Session Reinforcing Strong Anti-Hemolytic Profile of Mitapivat in Sickle Cell DiseaseRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Gheuens SarahOfficer (Chief Medical Officer)Sell -30,000 54,645 held$30.48 08/04/2026
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Hedge Fund 13F Activity

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)
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AGIO Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2027-01-15
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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How AGIO ranks across every disease it competes in

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See how AGIO ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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AGIO News

AGIO
Oct 8, 2026
AGIOConferences/Events
▼ -0.3%today

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 →
AGIO
Jul 30, 2026
AGIOGeneral
▼ -6.5%on this news

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.

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AGIO
Jul 21, 2026
AGIOPhases
▼ -6.7%on this news

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.

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AGIO
Jul 7, 2026
AGIOFDA Updates
▲ +17.7%on this news

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 →
AGIO
Jun 29, 2026
AGIOConferences/Events

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 →
AGIO
Jun 13, 2026
AGIOPhases
▲ +8%on this news

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.

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AGIO
Jun 1, 2026
AGIOFDA Updates

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.

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AGIO
May 29, 2026
AGIOPhases

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.

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AGIO
May 23, 2026
AGIOFDA Updates

Resumen: El socio de Avanzanite Bioscience, Agios anuncia la autorización de PYRUKYND® (mitapivat) en la Unión Europea para adultos con talasemia

Agios has announced the authorization of PYRUKYND® (mitapivat) in the European Union for adults with thalassemia. This marks a significant regulatory achievement for the company and its partner, Avanzanite Bioscience. The approval may enhance treatment options for patients suffering from this condition.

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AGIO
May 22, 2026
AGIOFDA Updates

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.

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AGIO
May 22, 2026
AGIOFDA Updates

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.

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AGIO
May 22, 2026
AGIOFDA Updates

Samenvatting: Avanzanite Bioscience’s partner Agios maakt de goedkeuring van PYRUKYND® (mitapivat) in de Europese Unie bekend voor volwassenen met thalassemie

Agios has announced the approval of PYRUKYND® (mitapivat) in the European Union for adults with thalassemia. This marks a significant milestone for the company and its partner, Avanzanite Bioscience. The approval is expected to enhance treatment options for patients suffering from this condition.

Read more →
AGIO
May 22, 2026
AGIOFDA Updates

Riassunto: Agios, partner di Avanzanite Bioscience, annuncia l'approvazione di PYRUKYND® (mitapivat) nell'Unione europea per gli adulti affetti da talassemia

Agios, in partnership with Avanzanite Bioscience, announced the approval of PYRUKYND® (mitapivat) in the European Union for adults with thalassemia. However, the article provides limited information regarding the implications of this approval or the approval process itself.

Read more →
AGIO
May 12, 2026
AGIOFDA Updates

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.

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AGIO
May 12, 2026
AGIOConferences/Events

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.

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AGIO
Apr 29, 2026
AGIOGeneral
▲ +13.1%on this news

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.

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AGIO
Apr 6, 2026
AGIOConferences/Events

Agios to Host First Quarter 2026 Financial Results Conference Call and Webcast on April 29 at 8:00 a.m. ET

Agios Pharmaceuticals, a biopharmaceutical company specializing in rare diseases, announced that it will host a conference call and live webcast on April 29, 2026, at 8:00 a.m. ET to discuss its first quarter 2026 financial results and business highlights. The event will be accessible through the Investors section of Agios' website, where a replay will also be available. The announcement reflects Agios' commitment to keeping investors informed about its operations and financial performance.

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AGIO
Mar 31, 2026
AGIOFDA Updates
▲ +14.3%on this newsshared move

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.

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AGIO
Mar 2, 2026
AGIOFDA Updates

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.

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About Agios Pharmaceuticals, Inc.

Cambridge, MA 540 employees agios.com
Headquarters88 SIDNEY STREET, CAMBRIDGE, MA, 02139
Founded2007
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