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News Breaks
March 19, 2014
08:08 EDTCELG, AGIOAgios Pharmaceuticals enrolls first patient in Phase 1 AG-120 study
Agios Pharmaceuticals (AGIO) announced that the first patient has been dosed in a Phase 1 study of AG-120 in patients with advanced hematologic malignancies with an isocitrate dehydrogenase-1 mutation. AG-120 is an orally available, selective, potent inhibitor of the mutated IDH1 protein, making it the first targeted therapeutic candidate to treat patients with cancers that harbor the IDH1 mutation. AG-120 is a part of Agios’ global strategic collaboration with Celgene (CELG). The Phase 1, multicenter, open-label, dose-escalation clinical trial of AG-120 is designed to assess the safety and tolerability of AG-120 as a single agent. The study is expected to only enroll subjects with an IDH1-mutant hematologic malignancy, including acute myelogenous leukemia and myelodysplastic syndrome. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.
News For AGIO;CELG From The Last 14 Days
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June 29, 2015
19:01 EDTCELGOn The Fly: After Hours Movers
HIGHER: Juno Therapeutics (JUNO), up 38.4% after announcing immunotherapy collaboration with Celgene (CELG)... Kite Pharma (KITE) and Lion Biotechnologies (LBIO) are up 8.7% and 5.7% respectively, following Juno's collaboration with Celgene. DOWN AFTER EARNINGS: CHC Group (HELI), down 8%... Apollo Education (APOL), down 6.2%. ALSO LOWER: EnteroMedics (ETRM), down 12.4% after filing to sell common stock and warrants... Celgene (CELG), down 1% after Juno announces immunotherapy collaboration.
18:09 EDTCELGJuno surges after Celgene collaboration, CAR-T peers follow
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16:09 EDTCELGCelgene, Juno Therapeutics announce ten year collaboration
Celgene (CELG) and Juno Therapeutics (JUNO) announced a global collaboration for the development and commercialization of immunotherapies. The two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on Chimeric Antigen Receptor Technology and T Cell Receptor technologies. Under the terms of the collaboration, Celgene has the option to be the commercialization partner for Juno’s oncology and cell therapy auto-immune product candidates, including Juno’s CD19 and CD22 directed CAR-T product candidates. B-Cell Maturation Antigen is excluded as a target in this collaboration. Under the terms of the collaboration, Celgene has the option to be the commercialization partner for Juno’s oncology and cell therapy auto-immune product candidates, including Juno’s CD19 and CD22 directed CAR-T product candidates. B-Cell Maturation Antigen is excluded as a target in this collaboration. For Juno-originated programs co-developed under the collaboration: Juno will be responsible for research and development in North America and will retain commercialization rights in those territories; Celgene will be responsible for development and commercialization in the rest of the world, and will pay Juno a royalty on sales in those territories; and Celgene has certain co-promotion options: Celgene will initially be eligible to select two programs, excluding CD19 and CD22, to be subject to a global profit sharing agreement under which the companies will share worldwide expenses and profits equally, except in China; and Additionally, subject to additional obligations, Celgene may select a third program. Juno will have the option to enter into a co-development and co-commercialization agreement on certain Celgene-originated development candidates that target T Cells. For any such Celgene-originated programs co-developed under the collaboration: The parties will share global costs and profits with 70% allocated to Celgene and 30% allocated to Juno; and Celgene will lead global development and commercialization, subject to a Juno co-promote option in the US and certain EU territories. Upon closing, Juno will receive an upfront payment of approximately $150M, and in addition Celgene will purchase 9,137,672 shares of Juno’s common stock at $93.00 per share. In conjunction with this stock purchase: Celgene will receive the right to nominate a member to Juno’s board of directors; During the 10-year term of the collaboration, Celgene will have the right to purchase additional equity in Juno during specified windows and at specified market premiums subject to satisfaction of certain conditions by each party including Juno opting in on select Celgene programs, such that, at a maximum, Celgene could own up to 30% of Juno’s common stock then outstanding; and Celgene has entered into a standstill agreement and agreed to certain lock-up provisions on its share ownership. This transaction has been approved by the boards of directors of both companies. Celgene and Juno currently expect to complete the transaction during the third quarter of 2015, subject to the expiration or termination of applicable waiting periods under all applicable antitrust laws and satisfaction of other usual and customary closing conditions.
16:08 EDTCELGJuno jumps 45% after announcing immunotherapy collaboration with Celgene
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16:07 EDTCELGCelgene, Juno Therapeutics announce ten year collaboration
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June 26, 2015
11:32 EDTCELGCelgene looks to protect itself from Kyle Bass patent challenges, WSJ says
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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.
June 17, 2015
07:32 EDTCELGCelgene announces additional $4B share repurchase authorization
Celgene Corporation announced that during its June meeting the company's Board of Directors authorized the repurchase of up to an additional $4B of the company's common stock. This open-ended program is effective immediately. Purchases may be made in the open market or in privately negotiated transactions from time to time, as determined by Celgene's management and in accordance with the requirements of the Securities and Exchange Commission. Celgene now has a total of approximately $5.2B remaining from previous authorizations plus the new authorization. Since 2009, Celgene has returned approximately $12.3B to shareholders through the repurchase program.
June 15, 2015
10:44 EDTAGIOAgios Pharmaceuticals price target lowered to $93 from $103 at Canaccord
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09:19 EDTAGIOBiotech Industry Organization to hold a conference
BIO 2015 is being held in Philadelphia on June 15-18.

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