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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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June 26, 2015
08:23 EDTAGIOAgios Pharmaceuticals management to meet with JPMorgan
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June 24, 2015
09:14 EDTAGIOAgios Pharmaceuticals management to meet with Leerink
Meeting to be held in Boston on June 29 hosted by Leerink.
07:32 EDTAGIOAgios Pharmaceuticals announces first patient dosed with AG-881 in Phase 1 study
Agios Pharmaceuticals announced dose administration for the first patient in a Phase 1, open-label, dose-escalation and expansion study of single agent AG-881, a small molecule that has shown in preclinical studies to fully penetrate the blood-brain barrier and inhibit isocitrate dehydrogenase-1 and IDH2 mutations in cancer models. The purpose of the Phase 1 multi-center, open-label study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced solid tumors. AG-881 will be administered continuously as a single agent dosed orally in a 28-day cycle. The first portion of the study includes a dose-escalation phase in which cohorts of patients will receive ascending oral doses of AG-881 to determine the maximum tolerated dose and/or the recommended Phase 2 dose based on safety and tolerability. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability and clinical activity of the recommended Phase 2 dose.

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