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Agios Pharmaceuticals, Inc.

AGIOFDA catalysts, PDUFA dates & pipeline intelligence
$37.23
▼ -0.89 · -2.33%

Financials

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52W LOW $22.2452W HIGH $46.00
Volume
984.41 K
Value Traded
34.92 M
Short % Float
11.84%
Days to Cover
5.6
+0.62%Week
+11.97%1 Month
+24.02%3 Month
+32.21%6 Month
-50.85%5 Year
-2.97%All Time

Cash Data

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Key Stats

Market Cap
2.22 B
EPS (TTM)
-6.89
P/E Ratio
-
Ent. Value
1.26 B
Total Shares
59.71 M
Float Shares
58.25 M
Insiders
2.42%
Institutions
116.70%

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 %
2026-07-21tebapivat Phase 2 topline data readout Phase 2
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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

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
4
Drugs Scored
rNPV / MCap
Top Drug
Top 12%
Small Cap
(rank 80 of 657)
Percentile Rank
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))
ProductRevenuePrior periodChange
PYRUKYND
Showing 16 of 18 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Mitapivat Small moleculeNCT04770779Transfusion-dependent Alpha-ThalassemiaPhase 3 ACTIVE NOT_RECRUITING 312Jun 1, 2029
Mitapivat Small moleculeNCT04770753Non-Transfusion-dependent Alpha-ThalassemiaPhase 3 ACTIVE NOT_RECRUITING 239Dec 1, 2028
Mitapivat Small moleculeNCT05175105Pediatric Pyruvate Kinase DeficiencyPhase 3 ACTIVE NOT_RECRUITING 79Jan 1, 2030
Mitapivat Small moleculeNCT05031780Sickle Cell DiseaseNDA/BLA ACTIVE NOT_RECRUITING 445Feb 1, 2030
AG-236 Small moleculeNCT07859423Polycythemia VeraPhase 2 NOT YET_RECRUITING 245Aug 1, 2032
Tebapivat Small moleculeNCT06924970Sickle Cell DiseasePhase 2 ACTIVE NOT_RECRUITING 59May 1, 2027
Tebapivat Small moleculeNCT05490446Myelodysplastic SyndromesPhase 2 ACTIVE NOT_RECRUITING 87Mar 1, 2029
AG-181 Small moleculeNCT07241234PhenylketonuriaPhase 1 RECRUITING 20Jan 17, 2028
AG-348 Small moleculeMarketedNCT03692052ThalassemiaPhase 2 ACTIVE NOT_RECRUITING 20Sep 30, 2030
Mitapivat Small moleculeMarketedNCT03853798Pyruvate Kinase DeficiencyPhase 3 COMPLETED 90Jul 3, 2024
Mitapivat Small moleculeMarketedNCT05610657Moderate Hepatic ImpairmentPhase 1 COMPLETED 20Jul 21, 2023
AG-946 Small moleculeCompletedNCT04536792Anemia, Sickle CellPhase 1 COMPLETED 122Dec 19, 2023
AG-348 Small moleculeMarketedNCT02476916Pyruvate Kinase DeficiencyPhase 3 COMPLETED 159Apr 2, 2025
AG-881 Small moleculeMarketedNCT02492737Acute Myeloid Leukemia (AML)Phase 1 COMPLETED 46Mar 21, 2018
AG-120 Small moleculeMarketedNCT03282513Hepatic ImpairmentPhase 1 COMPLETED 33Mar 31, 2018
ivosidenib Small moleculeMarketedNCT03071770UndisclosedPhase 1 COMPLETED 60Sep 6, 2017
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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)Option 7,866 62,511 held$25.01 10/26/2026
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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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Shares held by hedge funds each quarter, and who bought or sold.

AGIO Institutional Ownership Trends

AGIO Short Interest

Shares sold short, counted twice a month.

11.84%
Short % of Float
of tradable shares sold short
6.9M
Shares Sold Short
-1.7% vs prior count
5.6 High
Days to Cover
trading days of normal volume to buy every short share back
1.2M
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

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
2026-11-20
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Real-Time Option Chain

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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

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.

Read more →
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 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 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.

Read more →
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 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 →
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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AGIO
Feb 12, 2026
AGIOGeneral

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 →
AGIO
Jan 26, 2026
AGIOConferences/Events

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 →
AGIO
Jan 12, 2026
AGIOFDA Updates

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.

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AGIO
Jan 5, 2026
AGIOConferences/Events

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.

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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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