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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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December 11, 2014
09:16 EDTAGIOOn The Fly: Pre-market Movers
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08:25 EDTAGIOAgios Pharmaceuticals 1.98M share Secondary priced at $110.75
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December 9, 2014
18:21 EDTAGIOOn The Fly: After Hours Movers
UP AFTER EARNINGS: Korn/Ferry (KFY), up 3.1%... Analogic (ALOG), up 2.7%. DOWN AFTER EARNINGS: Freshpet (FRPT), down 8.5% after reporting quarterly results... Krispy Kreme (KKD), down 4.9%... Broadcom (BRCM), reverses to down just below 1%. ALSO LOWER: Agios Pharmaceuticals (AGIO), down 1.9% after filing to sell $175M of common stock... Yum! Brands (YUM), down 4.6% after providing fiscal 2015 operating guidance.
16:25 EDTAGIOAgios Pharmaceuticals files to sell $175M of common stock
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16:09 EDTAGIOAgios Pharmaceuticals files automatic mixed securities shelf
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December 8, 2014
13:02 EDTAGIOAgios Pharmaceuticals says Phase 1 AG-348 trials met primary endpoints
Agios Pharmaceuticals presented the first clinical data from its Phase 1 single and multiple ascending dose clinical trials of AG-348 in healthy volunteers. These results provide early proof-of-mechanism for AG-348, a novel, first-in-class, oral activator of both wild type and mutated pyruvate kinase-R enzymes. In these Phase 1 studies, dosing of AG-348 over 14-days in healthy volunteers resulted in a dose-dependent increase in the pyruvate kinase-R pathway as evidenced by a substantial increase in ATP and decrease in 2,3-DPG levels, which are key biomarkers of PKR activity and primary indicators of PK deficiency. These data support the hypothesis that AG-348 treatment may similarly enhance PKR activity in patients with PK deficiency and thus correct the underlying defect of the disease. These results will be presented during a poster session at the 56th Annual Meeting of the American Society of Hematology. The results being reported are from 64 healthy volunteers who received either AG-348 or placebo, which includes 48 people from the completed SAD study and 16 people in the first two cohorts of the ongoing MAD study that recently completed enrollment. Complete safety results are being reported from the SAD Phase 1 study and showed that AG-348 was well tolerated. Although the MAD study remains blinded, no serious adverse events have been reported in the first two analyzed cohorts. AG-348 also showed a favorable pharmacokinetic profile with rapid absorption, low variability and dose-proportional increase in exposure following both single and multiple doses. The observed dose-dependent changes in 2,3-DPG and ATP blood levels seen are consistent with a substantial increase in PKR enzymatic activity. The Phase 1 studies are randomized, double blind, placebo-controlled trials evaluating single ascending and multiple ascending oral doses for 14 days. The primary objectives of the studies are to assess safety and tolerability of AG-348 in healthy subjects and identify a safe and pharmacodynamically active dose and schedule for future studies in patients with PK deficiency. Secondary objectives are designed to characterize the pharmacokinetics of AG-348 and the PK/PD relationship between AG-348, ATP, and 2,3-DPG. Both trials successfully met their respective primary endpoints.
09:20 EDTAGIOOn The Fly: Pre-market Movers
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07:39 EDTAGIOAgios Pharmaceuticals volatility low into new data from Ongoing Phase 1 trial
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07:36 EDTAGIOAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.

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