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Agios Pharmaceuticals Inc (AGIO.OQ)

AGIO.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Agios presents updated phase 1 data from dose expansion cohort of ivosidenib
Friday, 17 Nov 2017 07:05am EST 

Nov 17 (Reuters) - Agios Pharmaceuticals Inc :Agios presents updated phase 1 data from dose expansion cohort of ivosidenib (AG-120) in patients with IDH1 mutant positive glioma.Agios Pharmaceuticals Inc - ‍ivosidenib well-tolerated in patients with low grade glioma​.Agios Pharmaceuticals Inc - ‍additional preclinical data demonstrate that ivosidenib and AG-881 suppress 2-HG levels in brain tumor mouse models​.Agios Pharmaceuticals Inc - ‍there were 5 patients with serious adverse events (SAE) and all were deemed unrelated to study treatment​.Agios Pharmaceuticals - ‍preliminary data suggest that both molecules suppress oncometabolite D-2-hydroxyglutarate in an orthotopic brain tumor model​.Agios Pharmaceuticals - study ‍to refine imaging methodology, assess biological effects of IDH inhibitors in perioperative study planned for H1 of 2018​.  Full Article

Agios reports Q3 revenue $11.4 million
Wednesday, 1 Nov 2017 07:00am EDT 

Nov 1 (Reuters) - Agios Pharmaceuticals Inc :Agios reports third quarter 2017 financial results.Q3 revenue $11.4 million versus I/B/E/S view $9.8 million.Agios Pharmaceuticals Inc - Qtrly ‍net loss per share $1.59.  Full Article

Agios posts Q2 loss per share $1.78‍​
Tuesday, 8 Aug 2017 07:01am EDT 

Aug 8 (Reuters) - Agios Pharmaceuticals Inc :Agios reports second quarter 2017 financial results.Agios Pharmaceuticals Inc - ‍collaboration revenue was $11.3 million for quarter ended June 30, 2017, compared to $7.0 million for comparable period in 2016​.Agios Pharmaceuticals Inc - ‍expects to submit an NDA (new drug application) to U.S. FDA for ivosidenib for IDH1M positive r/r AML by end of 2017​.Agios Pharmaceuticals Inc - ‍expects to submit ind application for AG-270, development candidate targeting mtap-deleted tumors, by end of 2017​.Agios Pharma - ‍expects cash, cash equivalents as of June 30, 2017, will enable company to fund its anticipated through at least end of 2019​.Agios Pharmaceuticals Inc qtrly loss per share $1.78‍​.Q2 earnings per share view $-1.56, revenue view $9.6 million -- Thomson Reuters I/B/E/S.  Full Article

Agios Pharma says FDA approves Idhifa for treating relapsed/refractory Acute Myeloid Leukemia
Tuesday, 1 Aug 2017 11:30am EDT 

Aug 1 (Reuters) - Agios Pharmaceuticals Inc :FDA grants approval of Idhifa, the first oral targeted therapy for adult patients with relapsed/refractory acute myeloid leukemia and an IDH2 mutation.  Full Article

Agios Pharmaceuticals says IDHIFA NDA given PDUFA action date of Aug. 30
Tuesday, 6 Jun 2017 12:26pm EDT 

June 6 (Reuters) - Agios Pharmaceuticals Inc ::Updated data from phase 1 trial of oral IDHIFA (enasidenib) demonstrate complete responses and duration of response in patients with relapsed or refractory AML and an IDH2 mutation.Overall safety profile was consistent with previously reported data for oral IDHIFA​.IDHIFA NDA has been given a prescription drug user fee act PDUFA action date of Aug. 30, 2017.  Full Article

Thermo Fisher Scientific signs development agreement with Agios Pharmaceuticals
Thursday, 18 May 2017 08:00am EDT 

May 18 (Reuters) - Thermo Fisher Scientific Inc :Thermo Fisher Scientific signs development agreement with Agios Pharmaceuticals for next-generation sequencing oncology companion diagnostic in cholangiocarcinoma.Thermo Fisher Scientific Co will retain rights to commercialize test globally and will lead necessary filings to seek clearance from regional regulatory agencies.Says under terms of agreement, Thermo Fisher will retain rights to commercialize test globally.Thermo Fisher Scientific says it will also lead all necessary filings to seek clearance from regional regulatory agencies.Thermo Fisher Scientific - upon validation of CDX, it will submit a supplemental premarket approval application to expand clinical claims for its multi-therapy NGS test.  Full Article

Agios and Aurigene enter into license agreement for novel small molecules for cancer metabolism target
Thursday, 27 Apr 2017 07:30am EDT 

April 27 (Reuters) - Agios Pharmaceuticals Inc :Agios and aurigene enter into exclusive license agreement for novel small molecules for cancer metabolism target.Agios pharmaceuticals inc - aurigene will provide agios exclusive rights to its portfolio of novel small molecules for undisclosed target.Agios pharmaceuticals inc - financial terms of agreement include a $3 million upfront payment.Agios-Deal inclides potential future milestone payments of up to $17 million per licensed product if certain milestones are achieved by agios.  Full Article

Agios announces proposed offering of common stock
Monday, 17 Apr 2017 04:01pm EDT 

April 17 (Reuters) - Agios Pharmaceuticals Inc -:Agios announces proposed offering of common stock.Agios Pharmaceuticals Inc says offering to sell to 4.5 million shares of its common stock in an underwritten public offering.Agios Pharmaceuticals - proceeds of offering are expected to be used to fund company's research, clinical development and pre-commercial activities.  Full Article

Agios Pharmaceuticals announces MTAP pathway research program and collaboration agreement with Celgene
Monday, 13 Mar 2017 07:30am EDT 

Agios Pharmaceuticals Inc : Agios announces MTAP pathway research program as development program and development candidate under master research and collaboration agreement with Celgene . Says Celgene will pay Agios an $8 million designation fee for MTAP pathway program . Agios Pharmaceuticals Inc - Celgene will have an opt-in right on program up through Phase 1 dose escalation for at least a $30 million fee . Agios Pharmaceuticals Inc - Agios will be eligible for up to $169 million in clinical and regulatory milestone payments .Agios Pharmaceuticals - co, Celgene to have global co-development and co-commercialization rights with worldwide 50/50 cost and profit share on MTAP pathway program.  Full Article

Agios says cash, marketable securities were $573.6 mln as of Dec. 31
Thursday, 16 Feb 2017 07:01am EST 

Agios Pharmaceuticals Inc : Agios reports fourth quarter and full year 2016 financial results and highlights key 2017 milestones . Agios Pharmaceuticals Inc - Cash, cash equivalents and marketable securities as of December 31, 2016 were $573.6 million .Agios Pharma- Expects existing cash, cash equivalents to fund anticipated operating expenses, capital expenditure requirements through at least end of 2018.  Full Article

BRIEF-Agios presents updated phase 1 data from dose expansion cohort of ivosidenib

* Agios presents updated phase 1 data from dose expansion cohort of ivosidenib (AG-120) in patients with IDH1 mutant positive glioma