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April 7, 2014
10:19 EDTAGIOAgios surges after blood cancer drug shows 'promising activity'
Shares of biopharmaceutical company Agios Pharmaceuticals (AGIO) are rising after the company reported that its blood cancer drug, AG-221, showed "promising clinical activity." WHAT'S NEW: Yesterday, Agios announced that it presented preliminary data from its lead, first-in-class program AG-221. The preliminary findings demonstrated the clinical activity, tolerability and unique mechanism of action of AG-221 in patients with advanced hematologic malignancies with an isocitrate dehydrogenase-2, or IDH2, mutation. The company said, "This is the first clinical trial of an inhibitor of mutant IDH, and while the primary objectives of this study are to determine the safety and tolerability of AG-221, we were also able to demonstrate promising clinical activity, including multiple complete remissions, in patients whose blood cancers carried an IDH2 mutation, even at the lowest tested dose. The treatment has been well tolerated to date, and as we have not yet achieved the maximum tolerated dose, the study continues to enroll patients." ANALYST REACTION: Today, JPMorgan upgraded Agios to Overweight from Neutral citing a declined risk profile following the company's "robust" interim phase 1 data on AG-221. The firm raised its price target for shares to $55 from $40. Analyst Geoff Meacham said that the new AG-221 data comprises the first clinical trial data to support what JPMorgan had already considered to be "very strong science" at the biopharaceutical company. He noted that the data was well ahead of expectations since six out of seven evaluated patients achieved a clinical response, with the majority of those being complete responses. Meacham said the firm is introducing AG-221 revenue models by projecting that the agent could peak at $1B globally, which increases the firm's estimate for Agios' total cancer program to over $3B in peak sales. PRICE ACTION: During morning trading, shares of Agios Pharmaceuticals jumped $7.82 or 22.04% to $43.30.
News For AGIO From The Last 14 Days
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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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