Agios Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery and development of medicines in the field of cellular metabolism and adjacent areas of biology. The company offers TIBSOVO (ivosidenib), an oral targeted inhibitor for treating adult patients with relapsed or refractory acute myeloid leukemia (R/R AML), as well as to treat patients with newly diagnosed AML; and IDHIFA (enasidenib), an oral targeted inhibitor for patients with R/R AML and an isocitrate dehydrogenase 2 mutation. It is also developing TIBSOVO, which has completed Phase II clinical trials to treat IC eligible frontline AML; that is in Phase III clinical trials for treating IC ineligible frontline AML; and that is in Phase III clinical trials for the treatment of cholangiocarcinoma, as well as in early stage clinical development to treat glioma and solid tumors. In addition, the company is developing IDHIFA, which has completed Phase II clinical study for treating IC eligible frontline AML; and that is in Phase I/II clinical trials for the treatment of IC ineligible frontline AML. Further, it is developing mitapivat, which is in Phase III clinical trials to treat pyruvate kinase deficiency, as well as in Phase II clinical study for treating thalassemia and sickle cell disease; vorasidenib (AG-881) that is in Phase I clinical trials for the treatment of solid tumors, including glioma; AG-270, which is in Phase I dose-escalation trial to treat methylthioadenosine phosphorylase deleted tumors; and AG-946 that is in Phase I clinical study for treating hemolytic anemias and other indications. Agios Pharmaceuticals, Inc. was incorporated in 2007 and is based in Cambridge, Massachusetts.
IPO Year: 2013
Exchange: NASDAQ
Website: agios.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/20/2026 | $65.00 → $50.00 | Buy | H.C. Wainwright |
| 11/24/2025 | Buy | Truist | |
| 11/20/2025 | $34.00 | Market Perform → Outperform | Leerink Partners |
| 11/19/2025 | $28.00 | Outperform → Sector Perform | RBC Capital Mkts |
| 2/24/2025 | $58.00 | Buy | H.C. Wainwright |
| 10/16/2024 | Sector Outperform | Scotiabank | |
| 10/10/2024 | $51.00 | Outperform | Raymond James |
| 9/27/2024 | $60.00 → $56.00 | Outperform → Market Perform | Leerink Partners |
| 2/8/2024 | Overweight | Cantor Fitzgerald | |
| 2/3/2023 | $41.00 | Overweight | Piper Sandler |
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H.C. Wainwright reiterated coverage of Agios Pharma with a rating of Buy and set a new price target of $50.00 from $65.00 previously
Truist initiated coverage of Agios Pharma with a rating of Buy
Leerink Partners upgraded Agios Pharma from Market Perform to Outperform and set a new price target of $34.00
RBC Capital Mkts downgraded Agios Pharma from Outperform to Sector Perform and set a new price target of $28.00
H.C. Wainwright initiated coverage of Agios Pharma with a rating of Buy and set a new price target of $58.00
Scotiabank initiated coverage of Agios Pharma with a rating of Sector Outperform
Raymond James resumed coverage of Agios Pharma with a rating of Outperform and set a new price target of $51.00
Leerink Partners downgraded Agios Pharma from Outperform to Market Perform and set a new price target of $56.00 from $60.00 previously
Cantor Fitzgerald initiated coverage of Agios Pharma with a rating of Overweight
Piper Sandler initiated coverage of Agios Pharma with a rating of Overweight and set a new price target of $41.00
SCHEDULE 13G - AGIOS PHARMACEUTICALS, INC. (0001439222) (Subject)
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SCHEDULE 13G - AGIOS PHARMACEUTICALS, INC. (0001439222) (Subject)
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8-K - AGIOS PHARMACEUTICALS, INC. (0001439222) (Filer)
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SCHEDULE 13G/A - AGIOS PHARMACEUTICALS, INC. (0001439222) (Subject)
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Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell diseaseSafety and tolerability of tebapivat were consistent with prior sickle cell disease trialssNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026 CAMBRIDGE, Mass., July 21, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced topline re
FDA’s PDUFA goal date is November 1, 2026If approved, mitapivat is positioned to become the first oral PK activator for patients with sickle cell disease CAMBRIDGE, Mass., July 07, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with a Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelera
CAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the company will host a conference call and live webcast on Thursday, July 30, 2026, at 8:00 a.m. ET to report its second quarter 2026 financial results and business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event. About Agios: Fueled by Connections t
Mitapivat demonstrated statistically significant improvement in hemoglobin response compared with placebo, with rapid onset and durable effectsNew analyses showed patients in mitapivat arm had clinically meaningful reduction in transfusion burden compared with placeboPatients in mitapivat arm who achieved hemoglobin response had clinically meaningful benefits across measures of sickle cell pain crises, fatigue, and other patient-reported outcomesMitapivat was well-tolerated, with a safety profile consistent with previous trials of mitapivat in sickle cell diseaseCompany to host investor conference call and webcast today at 9:00 a.m. ET (3:00 p.m. CEST) CAMBRIDGE, Mass., June 13, 2026 (GLO
Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor Agreement diversifies Agios' rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potentialOscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net salesAgios will host investor conference call and webcast today at 8:00 a.m. ET CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients wit
Results did not meet predefined threshold to support further development in LR-MDSTebapivat was well tolerated, with no new safety signals observed CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS). This decision follows results from its Phase 2b trial that did not meet the company's predefined threshold to support further development in this indication. The open-label, mu
Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation fo
PYRUKYND is the only medicine approved in the EU for adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemiaMitapivat is now approved for thalassemia in the U.S., Saudi Arabia, United Arab Emirates, and EUAvanzanite Bioscience B.V., a specialty pharmaceutical company, will continue to distribute and commercialize PYRUKYND in Europe CAMBRIDGE, Mass., May 22, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the European Commission (EC) has granted marketing authorization for PYRUKYND® (mitapivat),
sNDA submission follows agreement with FDA on confirmatory trial, a requirement of the accelerated approval pathway Confirmatory trial designed to demonstrate clinical benefit of mitapivat on reducing transfusion burden in sickle cell disease CAMBRIDGE, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the submission of its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the U.S. accelerated approval of mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease.
Detailed results from RISE UP Phase 3 trial of mitapivat in sickle cell disease selected for distinguished Plenary Abstracts Session Company to host investor conference call and webcast during EHA 2026 on Saturday, June 13, at 9:00 a.m. ET (3:00 p.m. CEST) CAMBRIDGE, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that new data on mitapivat, an oral pyruvate kinase (PK) activator, will be featured in oral and poster presentations during the 31st European Hematology Association (EHA) Congress (EHA 2026) in Stockhol
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for AGIOS PHARMACEUTICALS INC's drug PYRUKYND (ORIG-1) with active ingredient MITAPIVAT has changed to 'Approval' on 02/17/2022. Application Category: NDA, Application Number: 216196, Application Classification: Type 1 - New Molecular Entity
Submission status for AGIOS PHARMS INC's drug TIBSOVO (SUPPL-7) with active ingredient IVOSIDENIB has changed to 'Approval' on 03/18/2021. Application Category: NDA, Application Number: 211192, Application Classification: Labeling
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CAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the company will host a conference call and live webcast on Thursday, July 30, 2026, at 8:00 a.m. ET to report its second quarter 2026 financial results and business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event. About Agios: Fueled by Connections t
Mitapivat demonstrated statistically significant improvement in hemoglobin response compared with placebo, with rapid onset and durable effectsNew analyses showed patients in mitapivat arm had clinically meaningful reduction in transfusion burden compared with placeboPatients in mitapivat arm who achieved hemoglobin response had clinically meaningful benefits across measures of sickle cell pain crises, fatigue, and other patient-reported outcomesMitapivat was well-tolerated, with a safety profile consistent with previous trials of mitapivat in sickle cell diseaseCompany to host investor conference call and webcast today at 9:00 a.m. ET (3:00 p.m. CEST) CAMBRIDGE, Mass., June 13, 2026 (GLO
Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor Agreement diversifies Agios' rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potentialOscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net salesAgios will host investor conference call and webcast today at 8:00 a.m. ET CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients wit
Detailed results from RISE UP Phase 3 trial of mitapivat in sickle cell disease selected for distinguished Plenary Abstracts Session Company to host investor conference call and webcast during EHA 2026 on Saturday, June 13, at 9:00 a.m. ET (3:00 p.m. CEST) CAMBRIDGE, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that new data on mitapivat, an oral pyruvate kinase (PK) activator, will be featured in oral and poster presentations during the 31st European Hematology Association (EHA) Congress (EHA 2026) in Stockhol
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 2025Strong initial U.S. commercial launch of AQVESME in thalassemia, with 242 prescriptions written as of March 31, 2026Company plans to submit mitapivat sNDA for sickle cell disease in the second quarter of 2026Pipeline 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., April 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:
CAMBRIDGE, Mass., April 06, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the company will host a conference call and live webcast on Wednesday, April 29, 2026, at 8:00 a.m. ET to report its first quarter 2026 financial results and business highlights. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company's website approximately two hours after the event. About Agios: Fueled by Connections
PYRUKYND® (mitapivat) worldwide net revenues of $20.0 million in fourth quarter and $54.0 million for full yearAQVESME™ (mitapivat) for thalassemia now available in U.S. following FDA approvalCompany will have pre-sNDA meeting with FDA for mitapivat in sickle cell disease in first quarter of 2026Phase 2 tebapivat trial in sickle cell disease fully enrolled; topline results expected in second half of 2026$1.2 billion dollars in cash, cash equivalents, and marketable securities as of December 31, 2025 CAMBRIDGE, Mass., Feb. 12, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patie
CAMBRIDGE, Mass., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the company will host a conference call and live webcast on Thursday, February 12, 2026, at 8:00 a.m. ET to report its fourth quarter and full year 2025 financial results and business highlights. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company's website approximately two hours after the event. About Agios: Fuele
AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemiaMarketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S. brand name for PK deficiency indication AQVESME expected to be available in late January 2026, following AQVESME REMS program implementationCompany will host investor conference call and webcast tomorrow, December 24 at 8:00 a.m. ET CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare disea
Trial met primary endpoint of hemoglobin response and key secondary endpoints of change from baseline in hemoglobin concentration and indirect bilirubin Trial showed trend favoring mitapivat but did not meet statistical significance in primary endpoint of annualized rate of SCPCs (pain crises), and the key secondary endpoint of change from baseline in PROMIS Fatigue was not met Patients in the mitapivat arm who achieved hemoglobin response had clinically meaningful benefits in SCPC-related endpoints and PROMIS Fatigue Favorable safety profile observed in RISE UP Phase 3 trial was consistent with that observed in prior mitapivat sickle cell disease trials Company will share the comprehens
Live Leadership Updates
CAMBRIDGE, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced the appointment of Jay Backstrom, M.D., M.P.H., to its Board of Directors, effective immediately. Dr. Backstrom is an accomplished healthcare executive with a proven track record of advancing clinical programs across a range of therapeutic areas, including rare diseases, to regulatory approval. "We are thrilled to welcome Jay to the Agios Board of Directors," said Brian Goff, Chief Executive Officer, Agios. "His deep scientific insight, extensive regulatory expertise, and s
Cardurion Pharmaceuticals, Inc. ("Cardurion"), a clinical-stage biotechnology company discovering and developing new therapeutic approaches for the treatment of cardiovascular diseases, today announced that Charlotte (Charlie) Newman has joined the company as Chief Business Officer. A biopharmaceutical industry executive with over 25 years of industry experience, Ms. Newman most recently led corporate, portfolio and program strategy and business development as Chief Business Officer of Agios Pharmaceuticals (NASDAQ:AGIO), and previously held strategic product and portfolio roles at Biogen (NASDAQ:BIIB). In her role at Cardurion, she will be responsible for leading corporate development, bus
– John Maraganore Completes Tenure on Agios Board After Nearly a Dozen Years of Service – – Kaye Foster to Be Appointed Lead Independent Director – CAMBRIDGE, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Catherine Owen has been appointed to its board of directors, effective June 13, 2023. Agios also announced that, following a collaborative succession planning process, John Maraganore, Ph.D., who has served as a valuable board member and advisor to the company since 2011, will step down from the board of directors, effective immediately, and
– Board Member Paul Clancy Will Step Down at the End of His Term – CAMBRIDGE, Mass., April 19, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Jeffrey Capello has been appointed to its board of directors. Agios also announced that Paul Clancy will step down from the board of directors at the end of his term, effective June 13, 2023. "Agios is dedicated to cultivating a diverse board that is focused on the company's long-term value creation for patients and shareholders. As such, we are thrilled to welcome Jeff, whose nearly 30-year track record of driving profitab
EMERYVILLE, Calif., April 12, 2023 /PRNewswire/ -- Totus Medicines, the drug discovery and development company committed to ending the era of untreatable disease, announced today the appointment of Dr.Lewis Cantley, Dr. Hope Rugo, and Josep Tabernero to the company's Scientific Advisory Board (SAB). Totus has created the first biosearch technology that scans, maps, and decodes effective new drugs thousands of times faster than traditional drug discovery processes. To start, Totus has focused on oncology with an early breakthrough for the most mutated oncogene in cancer, PI3Kα, using the Totus Accel™ Platform.
CAMBRIDGE, Mass., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the appointment of Tsveta Milanova to the role of chief commercial officer, effective Jan. 3, 2023. Ms. Milanova will succeed Richa Poddar, who has been with Agios since 2016 and will continue to serve as the company's chief commercial officer until the end of the year. "Tsveta brings deep expertise in launching and commercializing medicines in rare disease and hematology, as well as international operations and global market access experience that will be a tremendous asset for Agios as we expan
CAMBRIDGE, Mass., Sept. 19, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for rare and genetically defined diseases, today announced the appointment of Cecilia Jones to the role of chief financial officer, effective Sept. 26, 2022. Ms. Jones will replace Jonathan Biller, who served as the company's previous chief financial officer and head of corporate affairs and who resigned effective Sept. 16, 2022 in order to become chief legal officer of Vertex Pharmaceuticals. "With more than two decades of experience in financial leadership roles with leading biopharmaceutical companies, including most recently
CAMBRIDGE, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced the appointments of Rahul Ballal, Ph.D., chief executive officer of Imara, and Cynthia Smith, former chief commercial officer of ZS Pharma, to its board of directors. "Agios is committed to assembling a top-notch, diverse board dedicated to realizing the company's long-term success and creating value for patients, shareholders, our team and all our stakeholders," said Brian Goff, chief executive officer of Agios. "Rahul and Cynthia are seasoned biopharmaceutical executives with cri
Maraganore brings more than 35 years of scientific, research and development, capital markets and managerial leadership expertise to ProKidney Fox joins Board with more than 25 years of healthcare investment banking, finance and capital markets experience WINSTON-SALEM, N.C., Aug. 11, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a leading clinical-stage cellular therapeutics company focused on therapies for chronic kidney disease ("CKD"), today announced the appointments of John M. Maraganore, Ph.D. and Jennifer Fox to its Board of Directors. "We are thrilled to welcome John and Jen to the ProKidney Board. They each have a wealth of experience t
CAMBRIDGE, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, today announced the appointment of Richa Poddar to the role of chief commercial officer, effective Dec. 6, 2021. Ms. Poddar will replace Darrin Miles, who currently serves as the company's chief commercial officer and has been with Agios since 2015. Mr. Miles will depart the company to pursue a chief executive officer role at a private biotechnology company. "During her more than five-year tenure at Agios, Richa has played a significant leadership role in shaping our oncology portfolio and leading our oncology la
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