Key Developments: Agios Pharmaceuticals Inc (AGIO.O)

AGIO.O on Nasdaq

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19 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Agios Pharmaceuticals announces U.S. FDA grants fast track designation to AG-221 for treatment of patients with Acute Myelogenous Leukemia That Harbor an IDH2 Mutation
Wednesday, 13 Aug 2014 08:30am EDT 

Agios Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AG-221 for treatment of patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.AG-221 is first-in-class, oral, selective, potent IDH2 mutant inhibitor being evaluated in Phase 1 clinical trial in patients with advanced hematologic malignancies.  Full Article

Agios Pharmaceuticals inc announces orphan drug designation of AG-221 for treatment of Acute Myelogenous Leukemia
Monday, 16 Jun 2014 08:00am EDT 

Agios Pharmaceuticals Inc:U.S. Food and Drug Administration (FDA) has granted company orphan drug designation for AG-221 for treatment of patients with acute myelogenous leukemia (AML).AG-221 is an oral, first-in-class IDH2 mutant inhibitor being evaluated in a Phase 1 clinical trial in patients with advanced hematologic malignancies that carry an IDH2 mutation.FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in U.S. Orphan drug designation provides to Agios.Says its collaborator Celgene certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.  Full Article

Agios Pharmaceuticals Inc announces clinical data from ongoing phase 1 Trial of AG-221 continue to show complete and durable remissions in patients with difficult to Treat Hematologic Malignancies
Saturday, 14 Jun 2014 07:31am EDT 

Agios Pharmaceuticals Inc:Says new clinical data from ongoing Phase 1 study of AG-221, which includes 35 patients with IDH2 mutant positive hematologic malignancies.These data confirm and build upon previously presented data on AG-221's clinical activity, safety profile and unique mechanism of action.New data show objective responses in 14 out of 25 evaluable patients on AG-221 and an additional five patients with stable disease.In six patients who achieved a complete remission (CR), evidence of durability was observed, ranging from one to four months in duration.All responses are ongoing. AG-221 continues to show favorable drug exposure and pharmacokinetics at all doses tested with substantial reductions in plasma levels of oncometabolite 2-hydroxyglutarate (2HG).Safety data show that AG-221 is well tolerated, with the majority of adverse events reported as mild to moderate.There were no discontinuations of AG-221 due to adverse events, and maximum tolerated dose has not been reached.These promising safety and efficacy data support the company's plan to initiate four expansion cohorts in the second half of 2014.  Full Article

Agios Pharmaceuticals Inc announces that Celgene exercised its option to license AG-221 under global strategic collaboration
Friday, 13 Jun 2014 08:03am EDT 

Agios Pharmaceuticals Inc:Says its partner Celgene Corporation has exercised its option to an exclusive worldwide license to AG-221, an oral, first-in-class, potent inhibitor of the mutant IDH2 protein.Under terms of the agreement, the option to license extended to Celgene through the end of Phase 1, but AG-221 has been exercised early based on the Phase 1 data generated to date.AG-221 is currently in a Phase 1 dose escalation study in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia (AML).In addition to contributing its scientific and translational expertise, will continue to conduct early clinical development and regulatory activities within the AG-221 development program in collaboration with Celgene.Celgene is responsible for all development costs for AG-221. Agios is eligible for up to $120 mln in milestone payments and a tiered royalty on any net sales. Agios also has the right to conduct a portion of any commercialization activities for AG-221 in the United States.  Full Article

Agios Pharmaceuticals Inc initiates multiple ascending Dose Trial in Healthy Volunteers of AG-348
Monday, 9 Jun 2014 08:00am EDT 

Agios Pharmaceuticals Inc:Initiation of multiple ascending dose (MAD) Phase 1 trial of AG-348 in healthy volunteers.This study is designed to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of AG-348 for 14 days.AG-348 is a novel, first-in-class, orally available activator of pyruvate kinase-R (PKR) for the treatment of pyruvate kinase (PK) deficiency, a rare, hemolytic anemia.This trial was initiated based on data from the ongoing single ascending dose (SAD) Phase 1 trial, in which AG-348 has been determined to be well tolerated to date.Says SAD study began in April 2014 and has completed dosing of more than half of the planned cohorts.Data from both studies are expected to be presented at a medical conference in 2015.  Full Article

Agios Pharmaceuticals Inc announces pricing of public offering of common stock
Wednesday, 23 Apr 2014 09:00pm EDT 

Agios Pharmaceuticals Inc:Announces pricing of underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $44.00 per share.Agios has granted the underwriters a 30-day option to purchase up to an additional 300,000 shares of common stock at the public offering price.Offering is expected to close on or about April 29.J.P. Morgan Securities LLC and Goldman, Sachs & Co. are acting as joint book-running managers.Cowen and Company, LLC and Leerink Partners LLC are serving as co-managers.  Full Article

Agios Pharmaceuticals announces proposed offering of common stock
Monday, 21 Apr 2014 04:01pm EDT 

Agios Pharmaceuticals Inc:Commenced an underwritten public offering of 2,000,000 shares of common stock.Intends to grant the underwriters a 30-day option to purchase up to an additional 300,000 shares of common stock sold in the offering.Proceeds of the offering are expected to be used to fund the company's clinical and research development activities. The offering is subject to market and other conditions.  Full Article

Agios Pharmaceuticals Inc initiates phase 1 study of AG-348
Thursday, 17 Apr 2014 08:00am EDT 

Agios Pharmaceuticals Inc:Announces dose administration of AG-348 in a phase 1 study in healthy volunteers.AG-348 is an orally available, potent, selective small molecule activator of pyruvate kinase-R (PK-R), a metabolic enzyme, which, when mutated, leads to pyruvate kinase (PK) deficiency, a rare, inherited hemolytic anemia.Phase 1, single-center, randomized, double-blind, placebo-controlled clinical trial will assess the safety and tolerability of AG-348 through dose escalation in healthy adult men and women.Key objectives of the trial include characterizing the safety, pharmacokinetic and pharmacodynamic relationships of AG-348 and select metabolic biomarkers.  Full Article

Agios Pharmaceuticals Inc exercises option to u.S. development and commercialization rights for IDH1 Program under Celgene Collaboration
Monday, 3 Feb 2014 08:00am EST 

Agios Pharmaceuticals Inc:Says it has elected to retain the United States development and commercial rights to the isocitrate dehydrogenase 1 (IDH1) program including the clinical candidate AG-120, in accordance with the terms of its global strategic collaboration with Celgene Corporation in the field of cancer metabolism.Says by exercising Agios' option to U.S. rights for the IDH1 program, Agios will lead development and commercialization activities for AG-120 in the U.S., and Celgene retains the option to lead development and commercialization activities for AG-120 in the rest of the world.Says Agios and Celgene are also collaborating on the development of AG-221.  Full Article

Agios Pharmaceuticals Inc Closes Initial Public Offering
Monday, 29 Jul 2013 05:00pm EDT 

Agios Pharmaceuticals Inc announced that the closing of its initial public offering of 6,772,221 shares of its common stock at a public offering price of $18.00 per share, before underwriting discounts, including 883,333 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discount. J.P. Morgan and Goldman, Sachs & Co. acted as joint book-running managers for the offering. Cowen and Company and Leerink Swan acted as co-managers.  Full Article

Agios leukemia drug shows promise in tiny, early study

- An experimental drug being developed by Agios Pharmaceuticals Inc showed promising anti-cancer activity in a tiny Phase I study of patients with relapsed acute myeloid leukemia (AML), according to data presented on Sunday.

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