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Stock Market & Financial Investment News

News Breaks
March 27, 2014
10:00 EDTCOMM, TCB, REGN, ICLR, CELG, AMGN, USPH, RNDY, PCYC, GILD, BIIB, ACPW, KING, RNG, IRT, CIG, ASBCOn The Fly: Analyst Initiation Summary
Active Power (ACPW) initiated with a Buy at Roth Capital... Amgen (AMGN) initiated with an Overweight at Morgan Stanley... Associated Banc-Corp (ASBC) initiated with a Neutral at DA Davidson... Biogen (BIIB) initiated with an Overweight at Morgan Stanley... Celgene (CELG) initiated with an Equal Weight at Morgan Stanley... Cemig (CIG) initiated with a Buy at Goldman... Gilead (GILD) initiated with an Equal Weight at Morgan Stanley... ICON plc (ICLR) initiated with an Outperform at Credit Suisse... Independence Realty Trust (IRT) initiated with a Buy at Deutsche Bank... Pharmacyclics (PCYC) initiated with an Equal Weight at Morgan Stanley... Regeneron (REGN) initiated with an Equal Weight at Morgan Stanley... RingCentral (RNG) initiated with an Outperform at Macquarie... Roundy's (RNDY) initiated with a Buy at BofA/Merrill... TCF Financial (TCB) initiated with a Neutral at DA Davidson... King Digital (KING) initiated with a Neutral at Sterne Ageel... U.S. Physical Therapy (USPH) initiated with an Overweight at Stephensl... CommScope (COMM) initiated with a Buy at Longbow.
News For ACPW;AMGN;ASBC;BIIB;CELG;CIG;GILD;ICLR;IRT;PCYC;REGN;RNG;RNDY;TCB;KING;USPH;COMM From The Last 14 Days
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December 8, 2014
16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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16:00 EDTGILDOptions Update; December 8, 2014
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14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:54 EDTCELGCelgene announces results from phase lll Revlimid study
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13:45 EDTPCYCTG Therapeutics says TG-1101 well tolerated in Phase 2 study
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10:02 EDTGILDGilead presents follow-up data from Zydelig registrational studies
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09:09 EDTAMGNAmgen announces FDA approval for XGEVA
Amgen announced that the FDA has approved a new indication for XGEVA for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. HCM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis.1,2 The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death. The approval of XGEVA is based on positive results from an open-label, single-arm study, which enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium <11.5 mg/dLwithin 10 days after the first dose of XGEVA. Secondary endpoints included the proportion of patients who experienced a complete response (defined as CSC <10.8 mg/dL by day 10, time to response and response duration. The study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. The overall complete response rate was 63.6 percent. The estimated median time to response was nine days, and the median duration of response was 104 days.4,5
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
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08:32 EDTPCYCTrout Group to hold events at ASH 2014
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07:36 EDTCELGAgios 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.
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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05:42 EDTAMGNSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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December 7, 2014
16:40 EDTCELGAgios announces new data from Ongoing Phase 1 trial of AG-221
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14:54 EDTPCYCIMBRUVICA data suggests promise in multiple myeloma
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14:38 EDTAMGNAmgen announces new data from Phase 2 BLINCYTO immunotherapy study
Amgen announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager, BiTE, immunotherapy BLINCYTO in patients with minimal residual disease, MRD, positive B-cell precursor acute lymphoblastic leukemia, ALL. In the study, 78% of patients who received BLINCYTO experienced a complete MRD response , a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses occurred within the first treatment cycle. The results from the BLAST study will be featured during the 56th American Society of Hematology Annual Meeting and Exposition press briefing on Saturday, December 6, at 10 a.m. PT and will be presented in an oral session at ASH on Monday, December 8, at 10:30 a.m. PT. "BLINCYTO is the most advanced of Amgen's BiTE immunotherapies, a new and innovative approach that helps the body's own immune system fight cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Achieving molecular complete remission is an important goal in the treatment of ALL, and the data presented at ASH demonstrates that BLINCYTO can produce deep responses in patients that have trace amounts of residual disease." MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD. In addition to the majority of patients achieving a compete MRD response within one cycle of treatment, 80% achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified. In the study, adverse events of all grades occurring in 20% or more patients included pyrexia, tremor, chills, fatigue, nausea, vomiting and diarrhea. Grade =3 AEs occurring in five percent or more patients included neutropenia , pyrexia and tremor. Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza. Treatment interruptions due to AEs occurred in 31% of patients.
14:18 EDTAMGNAmgen, Onyx announce detailed results from Phase 3 ASPIRE study of Kyprolis
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14:10 EDTCELG, AMGNAmerican Society of Hematology to hold a meeting
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13:16 EDTCELGCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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December 6, 2014
09:28 EDTCELGCelgene to hold an analyst and investor event
Analyst and Investor Event being held in conjunction with the American Society of Hematology's 56th Annual Meeting in San Francisco on December 7 at 11 pm. Webcast Link
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