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Agios Pharmaceuticals Inc (AGIO.OQ)

AGIO.OQ on NASDAQ Stock Exchange Global Select Market

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16 Jul 2019
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Latest Key Developments (Source: Significant Developments)

Agios Announces FDA Approval Of SNDA For Tibsovo
Thursday, 2 May 2019 

May 2 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR TIBSOVO® AS MONOTHERAPY FOR NEWLY DIAGNOSED ADULT PATIENTS WITH IDH1 MUTANT ACUTE MYELOID LEUKEMIA (AML) NOT ELIGIBLE FOR INTENSIVE CHEMOTHERAPY.AGIOS PHARMA - SNDA APPROVAL BASED ON NEWLY DIAGNOSED PATIENTS FROM PHASE 1 OF TIBSOVO IN ADVANCED HEMATOLOGIC MALIGNANCIES WITH IDH1 MUTATION.  Full Article

Agios Gets FDA Breakthrough Therapy Designation For Tibsovo In Combination With Azacitidine
Tuesday, 26 Mar 2019 

March 26 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION FOR TIBSOVO® (IVOSIDENIB) IN COMBINATION WITH AZACITIDINE FOR THE TREATMENT OF NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WITH AN IDH1 MUTATION IN ADULT PATIENTS INELIGIBLE FOR INTENSIVE CHEMOTHERAPY.  Full Article

Agios Pharmaceuticals Announces FDA Acceptance Of Supplemental New Drug Application For Tibsovo
Wednesday, 20 Feb 2019 

Feb 20 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS ANNOUNCES FDA ACCEPTANCE OF SUPPLEMENTAL NEW DRUG APPLICATION FOR TIBSOVO® (IVOSIDENIB) FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA WITH AN IDH1 MUTATION NOT ELIGIBLE FOR STANDARD THERAPY.AGIOS PHARMACEUTICALS INC - SNDA WAS GRANTED PRIORITY REVIEW AND HAS BEEN GIVEN A PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE OF JUNE 21, 2019.AGIOS PHARMACEUTICALS INC - SNDA WAS GRANTED PRIORITY REVIEW AND HAS BEEN GIVEN A PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE OF JUNE 21, 2019..  Full Article

Agios Qtrly Net Loss Per Share $1.58
Thursday, 14 Feb 2019 

Feb 14 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS.QTRLY NET LOSS PER SHARE $1.58.QTRLY TOTAL REVENUE $30 MILLION VERSUS $9.8 MILLION.Q4 EARNINGS PER SHARE VIEW $-1.67 -- REFINITIV IBES DATA.Q4 REVENUE VIEW $18.8 MILLION -- REFINITIV IBES DATA.  Full Article

Agios Presents Updated Data From Ivosidenib Phase 1 Trial
Monday, 3 Dec 2018 

Dec 3 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS PRESENTS UPDATED DATA FROM THE IVOSIDENIB PHASE 1 DOSE-ESCALATION AND EXPANSION TRIAL IN IDH1 MUTANT POSITIVE PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) INELIGIBLE FOR STANDARD TREATMENT AND MYELODYSPLASTIC SYNDROME (MDS).AGIOS PHARMACEUTICALS INC - SUPPLEMENTAL NDA FOR SINGLE AGENT TIBSOVO ON TRACK FOR SUBMISSION BY END OF JANUARY 2019.AGIOS - IVOSIDENIB DEMONSTRATED CR+CRH RATE OF 42.4% & ORR OF 57.6% IN NEWLY DIAGNOSED AML PATIENTS INELIGIBLE FOR STANDARD TREATMENT.  Full Article

Agios Reports Third Quarter 2018 Financial Results
Thursday, 1 Nov 2018 

Nov 1 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.QTRLY REVENUE $15.2 MILLION VERSUS 11.4 MILLION.QTRLY LOSS PER SHARE $1.63.Q3 EARNINGS PER SHARE VIEW $-1.62 -- THOMSON REUTERS I/B/E/S.Q3 REVENUE VIEW $19.1 MILLION -- THOMSON REUTERS I/B/E/S.CURRENT CASH POSITION WILL ENABLE COMPANY TO FUND OPERATING. EXPENSES AND CAPEX THROUGH AT LEAST END OF 2020.  Full Article

Agios Reports Qtrly Loss Per Share $1.81
Wednesday, 14 Feb 2018 

Feb 14 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS.QTRLY LOSS PER SHARE $1.81.QTRLY TOTAL REVENUE $9.8 MILLION VERSUS $22.6 MILLION.Q4 EARNINGS PER SHARE VIEW $-1.66 -- THOMSON REUTERS I/B/E/S.AGIOS PHARMACEUTICALS - SEES CASH, CASH EQUIVALENTS AS OF DEC 31, 2017 ENABLING CO TO FUND EXPENSES, CAPEX REQUIREMENTS THROUGH AT LEAST END OF 2020.  Full Article

Agios prices offering of 7.09 mln shares at $67 per share
Friday, 19 Jan 2018 

Jan 18 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS ANNOUNCES PRICING OF $475 MILLION PUBLIC OFFERING OF COMMON STOCK.AGIOS PHARMACEUTICALS - ‍IT HAS PRICED AN UNDERWRITTEN PUBLIC OFFERING OF 7.09 MILLION SHARES OF COMMON STOCK AT A PRICE TO PUBLIC OF $67.00 PER SHARE​.  Full Article

Agios Outlines Key 2018 Priorities Expanding Clinical And Research Programs To Drive Long Term Value
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS OUTLINES KEY 2018 PRIORITIES EXPANDING CLINICAL AND RESEARCH PROGRAMS TO DRIVE LONG TERM VALUE.AGIOS PHARMACEUTICALS INC - SEVENTH IND SUBMISSION FOR A DHODH INHIBITOR FOR TREATMENT OF HEMATOLOGIC MALIGNANCIES EXPECTED IN 4Q 2018.AGIOS - 2017 YEAR END CASH, CASH EQUIVALENTS & MARKETABLE SECURITIES OF $568M FUNDS EXPANDED CLINICAL & RESEARCH PROGRAMS THROUGH END OF 3Q 2019.AGIOS PHARMACEUTICALS INC - TWO PIVOTAL TRIALS IN PYRUVATE KINASE DEFICIENCY WITH AG-348, ACTIVATE-T TO INITIATE IN 1Q 2018 AND ACTIVATE IN 2Q 2018.AGIOS PHARMACEUTICALS INC - PHASE 2 PROOF OF CONCEPT TRIAL OF AG-348 IN THALASSEMIA PLANNED FOR 4Q 2018.AGIOS PHARMACEUTICALS INC - MAT2A INHIBITOR AG-270 EXPECTED TO ENTER PHASE 1 DOSE-ESCALATION TRIAL IN MTAP-DELETED TUMORS IN 1Q 2018.  Full Article

Agios Submits New Drug Application To The FDA For Ivosidenib
Tuesday, 26 Dec 2017 

Dec 26 (Reuters) - Agios Pharmaceuticals Inc ::AGIOS SUBMITS NEW DRUG APPLICATION TO THE FDA FOR IVOSIDENIB FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY AML AND AN IDH1 MUTATION.AGIOS PHARMACEUTICALS INC - EXPECTS TO INITIATE PHASE 1 TRIAL FOR AG-270 IN Q1 OF 2018.AGIOS PHARMACEUTICALS INC - ‍ANNOUNCES FDA CLEARANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR AG-270 TARGETING MTAP-DELETED TUMORS​.  Full Article