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June 15, 2014
14:22 EDTAGIOAgios announces new data from ongoing Phase 1 study of AG-221
Agios Pharmaceuticals announced new clinical data from the 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. The data were presented today in a late-breaker oral presentation at the 19th Congress of the European Hematology Association, EHA, in Milan, Italy by Stéphane de Botton, M.D., the principal investigator at the Institut de Cancérologie Gustave Roussy, Villejuif, France.
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November 20, 2014
08:03 EDTAGIOAgios Pharmaceuticals price target raised to $124 from $90 at Leerink
Leerink raised its price target for Agios Pharmaceuticals shares to $124 after the company presented initial data from AG-120 in acute myeloid leukemia that showed "robust activity." Leerink views Agios as an "interesting name" for 2015 with solid tumor data on AG-120 and keeps an Outperform rating on the stock.
November 19, 2014
09:16 EDTAGIOOn The Fly: Pre-market Movers
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09:02 EDTAGIOAgios Pharmaceuticals to host conference call
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08:18 EDTAGIOAgios Pharmaceuticals price target raised to $111 from $97 at Canaccord
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November 18, 2014
18:05 EDTAGIOAgios Pharmaceuticals reports early Phase 1 data from AG-120 trial
Agios Pharmaceuticals announced the first reported safety and clinical activity for AG-120 from the ongoing Phase 1 dose escalation study in patients with IDH1-mutant positive advanced hematologic malignancies, including acute myeloid leukemia. Agios has exclusive U.S. development and commercial rights to AG-120, a first-in-class, oral, selective, potent inhibitor of the mutant IDH1 enzyme. Daniel Pollyea, M.D., clinical investigator at the University of Colorado School of Medicine, will present the data in a late-breaking oral presentation at the 26th Annual EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held in Barcelona, Spain. The company will webcast an investor conference call from the symposium at 10:00 a.m. EST on Wednesday, November 19. As of October 17, the ongoing Phase 1 trial for AG-120 had enrolled 17 patients with a documented IDH1 mutation whose cancer relapsed or failed to respond to at least one prior treatment regimen. At the time of the data cut, 14 patients with relapsed and/or refractory AML were evaluable; three patients recently initiated therapy and were not evaluable. The initial data showed investigator assessed objective responses in seven out of 14 evaluable patients, including four complete remissions, with responses observed across the four dose levels tested, and early evidence of durability. One additional patient remains stable on study. AG-120 was well tolerated, with the majority of adverse events reported as mild to moderate. The maximum tolerated dose has not yet been reached. One patient had a dose limiting toxicity of asymptomatic grade 3 QT prolongation at the highest dose tested to date, which improved to grade 1 after AG-120 dose reduction according to treatment protocol. This patient is in complete remission and remains on AG-120. AG-120 showed favorable drug exposure and pharmacokinetics at all doses tested and also substantially reduced plasma levels of the oncometabolite 2-hydroxyglutarate, which is produced by the mutant IDH1 protein, to the level observed in healthy volunteers. The mechanism of response is consistent with differentiation, as evidenced by the maturation of the leukemic cells into infection fighting white blood cells, or neutrophils. Based on these findings, the company plans to initiate multiple expansion cohorts in the first half of 2015.
07:20 EDTAGIOEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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