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January 27, 2014
04:55 EDTFCSC, FCSC, FCSC, SNY, SNY, SNY, GSK, GSK, GSK, NVS, NVS, NVS, PFE, PFE, PFE, SAFC, SAFC, SAFC, CLDX, CLDX, CLDX, CELG, CELG, CELG, WX, WX, WX, XON, XON, XON, OPXA, OPXA, OPXA, BLUE, BLUE, BLUE, BIIB, BIIB, BIIBPhacilitate to hold a forum
Cell & Gene Therapy Forum 2014 is being held in Washington, D.C. on January 27-29.
News For FCSC;BLUE;OPXA;XON;WX;CELG;CLDX;SAFC;PFE;NVS;GSK;SNY;BIIB From The Last 14 Days
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November 10, 2014
16:28 EDTCLDXOncothyreon, Celldex announce initiation of ONT-10, varlilumab clinical trial
Oncothyreon Inc. (ONTY) and Celldex Therapeutics (CLDX) announced that they have initiated a combined clinical trial of ONT-10 and varlilumab. ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1. Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes. The trial is an open-label Phase 1b study of ONT-10 administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer. The primary objective of the trial is to determine the safety and tolerability of the combined therapy. Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses, T-cell activation markers and levels of regulatory T-cells, and anti-tumor effects. The Phase 1b trial will be conducted by Oncothyreon under the terms of a previously announced collaboration agreement between Oncothyreon and Celldex. The two companies will jointly own the data from the trial and will make any plans for potential future development of the combination therapy together. Under the agreement, neither company has granted the other a license, or any other rights, to its product candidate.
16:07 EDTNVS, GSKUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.
15:57 EDTNVSWorldwide Business Research to hold a conference
ProcureCon for Digital & Marketing Services 2014 is being held in San Antonio on November 11-13.
15:54 EDTSNYAmerican Society of Nephrology to hold a conference
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07:19 EDTCELGCredit Suisse to hold a conference
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07:08 EDTBLUEbluebird bio names James DeTore as CFO, treasurer
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November 7, 2014
08:13 EDTFCSCFibrocell Science reports Q3 EPS (15c), consensus (14c)
Reports Q3 revenue $20,000, consensus $80,000.
November 6, 2014
16:14 EDTOPXAOpexa Therapeutics reports Q3 EPS (14c), consensus (15c)
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16:13 EDTOPXAOpexa Therapeutics reports Q3 EPS (14c), consensus (15c)
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15:13 EDTSNYAmerican Association for Study of Liver Diseases to hold a meeting
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12:48 EDTNVSNovartis: FDA Advisory Committee does not recommend LBH589
Novartis announced that the US FDA's Oncologic Drugs Advisory Committe did not recommend the investigational compound LBH589, a pan-deacetylase inhibitor, for patients with previously treated multiple myeloma when used in combination with bortezomib and dexamethasone. The Committee's vote will be considered by the FDA in its review of the LBH589 new drug application, but the FDA is not bound to follow the Committee's guidance. The final decision regarding US approval is made by the FDA. "We are disappointed by this voting outcome and believe the results from our clinical trials provide strong evidence to support LBH589 as a potential first- in-class treatment option for multiple myeloma, a cancer where an unmet patient need exists," said Bruno Strigini, President, Novartis Oncology. "We will continue to work with the FDA as it completes its review of the US application."
11:40 EDTBLUEbluebird bio data still maturing, says Piper Jaffray
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11:00 EDTCELGAgios Pharmaceuticals falls after abstracts for ASH meeting posted
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10:59 EDTBLUEbluebird bio provides development update, says Cowen
Cowen said bluebird bio's additional data from the Northstar study showed one new patient is responding more slowly than the two betahalassemia patients who responded more quickly and became transfusion independent. The analyst said the important news is that the patient is responding and bluebird will present additional data at ASH
10:41 EDTBLUEbluebird bio falls after additional data from Northstar study disclosed
Shares of bluebird bio (BIO) are moving lower in early trading after an abstract containing additional details from a company study was posted to the website of the American Society of Hematology, or ASH. WHAT'S NEW: The presentation, entitled "Initial Results from the Northstar Study: A Phase 1/2 Study of Gene Therapy for ‑Thalassemia Major Via Transplantation of Autologous Hematopoietic Stem Cells Transduced Ex Vivo with [LentiGlobin BB305 Drug Product]," is scheduled to be presented orally on December 8 at the ASH meeting. A summary of the results states that, as of 31 July, 3 subjects have undergone HSC collection and ex-vivo LentiGlobin BB305 gene transfer. One subject has undergone myeloablation and drug product infusion. Last June, Bluebird reported that following a single infusion of LentiGlobin gene therapy, two B-thal patients started producing functional hemoglobin and within 10 and 12 days, respectively, were able to halt blood transfusions, noted Adam Feuerstein of TheStreet. The third beta-thal patient treated with Bluebird's gene therapy is not improving as quickly, the abstract indicates. PRICE ACTION: Shares of bluebird bio are down 4.6% to $37.22 in early trading following the posting of the abstract.
09:36 EDTPFEGlycoMimetics announces presentation of GMI-1271, rivipansel
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09:34 EDTCELGAcceleron Pharma announces presentation of ACE-536, ACE-011 data
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07:43 EDTBIIBIsis Pharmaceuticals earns $10M milestone payment from Biogen
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07:16 EDTNVSFDA Oncologic Drugs Advisory Committee to hold a meeting
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06:35 EDTPFEAstraZeneca CEO says tax revisions cripple new Pfizer offer, Reuters says
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