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April 23, 2014
04:55 EDTMBLTY, MBLTY, MBLTY, AZN, AZN, AZN, PFE, PFE, PFE, JNJ, JNJ, JNJ, MRK, MRK, MRK, NBS, NBS, NBS, XOMA, XOMA, XOMA, NVO, NVO, NVO, SNY, SNY, SNY, LLY, LLY, LLYGlobal Technology Community to hold a summit
7th Annual Diabetes Summit is being held in Cambridge, MA on April 23-25.
News For MBLTY;SNY;NVO;XOMA;NBS;MRK;JNJ;PFE;AZN;LLY From The Last 14 Days
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July 22, 2015
09:07 EDTXOMA, AZNOn The Fly: Pre-market Movers
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08:40 EDTLLYEli Lilly July weekly volatility elevated into Q2 and Alzheimer's drug data
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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08:31 EDTXOMAXOMA resumes, drops 63% after gevokizumab study misses primary endpoint
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08:08 EDTXOMAXOMA to resume trading at 8:30 am EDT after trial misses endpoint
Shares of antibody-based therapeutics maker XOMA were halted for trading before the company announced that a Phase 3 study of gevokizumab in patients with Behçet's disease uveitis did not meet the primary endpoint of time to first acute ocular exacerbation. The stock is scheduled to resume quotation at 8:25 am EDT and resume trading at 8:30 am EDT, according to Nasdaq.
08:02 EDTXOMAXOMA Phase 3 EYEGUARD-B study of gevokizumab did not meet primary endpoint
XOMA announced the Phase 3 EYEGUARD-B study of gevokizumab in patients with Behçet's disease uveitis, run by its partner Servier, an independent French pharmaceutical research company driven by the pursuit of innovative drugs, did not meet the primary endpoint of time to first acute ocular exacerbation. "Although the study did not achieve its main objective, we did see signals of drug activity such as preserved visual acuity, less severe ocular exacerbations and a reduced incidence of reported macular edema in patients treated with gevokizumab," said Paul Rubin MD, Senior Vice President Research and Development and Chief Medical Officer. "We will continue to work closely with our partner, Servier, and uveitis experts to conduct a thorough analysis of the data to fully understand gevokizumab's impact on several clinically relevant endpoints." Gevokizumab appeared to be well tolerated in the trial. Adverse events were comparable between gevokizumab and placebo treated groups.
08:02 EDTXOMAXOMA Phase 3 EYEGUARD-B study of gevokizumab did not meet primary endpoint
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07:59 EDTXOMAXOMA trading halted, pending news
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07:18 EDTLLYEli Lilly drops 3% to $83 after reporting Alzheimer's drug data
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07:06 EDTLLYEli Lilly's solanezumab for Alzheimer's supports 'delayed-start' use
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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:36 EDTXOMAXOMA volatility elevated into expected release of Phase III data
XOMA August call option implied volatility is at 287, September is at 228, December is at 167; compared to its 52-week range of 71 to 299, suggesting large price movement into expected release Phase III data for gevokizumab in Behçet’s disease uveitis.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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05:27 EDTXOMAStocks with implied volatility above IV index mean; XOMA AMZN
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
July 21, 2015
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
July 20, 2015
08:12 EDTXOMAXOMA volatility elevated into expected release of Phase III data
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07:32 EDTLLYAlzheimer's Association to hold a conference
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06:06 EDTXOMAStocks with implied volatility above IV index mean; XOMA TWTR
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