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April 23, 2014
04:55 EDTDNA, DNA, DNA, AMGN, AMGN, AMGN, PFE, PFE, PFE, BIO, BIO, BIO, BIIB, BIIB, BIIB, MRK, MRK, MRK, ASTX, ASTX, ASTX, SNY, SNY, SNY, GSK, GSK, GSKCambridge Healthtech Institute to hold a conference
9th Annual Drug Discovery Chemistry Conference is being held in San Diego, CA on April 23-25.
News For DNA;AMGN;PFE;BIO;BIIB;MRK;ASTX;SNY;GSK From The Last 14 Days
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July 23, 2015
09:10 EDTAMGNAmgen submits NDA for Kyprolis in relapsed multiple myeloma
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.
08:03 EDTBIIBBiogen update 'promising,' says RBC Capital
RBC Capital says that there were negative aspects to yesterday's update on the trial results of Biogen's Alzheimer's treatment. Specifically, the 6 mg version of the drug only slightly improved patients' performance on one cognition test compared with the most recently chosen group of ten patients taking placebos, and did not improve their performance at all on another cognition test. However, RBC says that the drug did improve patients' performance on both tests versus the 20+ patients who were in a previous placebo group. Additionally, the firm reports that the cognition test on which the patients taking the drug outperformed versus the newer placebo group is more widely accepted than the other cognition test. RBC sees a 50%-60% chance that the drug will succeed.
07:00 EDTBIIBBiogen July weekly volatility elevated into Q2 and outlook
Biogen July weekly call option implied volatility is at 77, August is at 37, September is at 34; compared to its 52-week range of 23 to 46, suggesting large near term price movement into the expected release of Q2 results on July 24.
July 22, 2015
10:59 EDTBIIBBiogen drops after reporting data on Alzheimer's drug
The shares of Biogen (BIIB) are falling after the company released data on its Alzheimer's treatment candidate, aducanumab. Peer Eli Lilly (LLY) also reported data this morning on its own experimental Alzheimer's drug, solanezumab. BIOGEN: Biogen's data "does not inspire confidence," Piper analyst Joshua Schimmer wrote in a note to investors today. The 6 mg dose of the drug performed similarly to the 1mg dose, and was barely better than the placebo, the analyst stated. The cognitive and functional performance of the patients who took the 6 mg dose did not improve by a statistically significant amount, while the results of patients taking the other doses were "noisy,"Schimmer stated. Additionally, indications of excess fluid in the brain was observed in a significant number of patients, representing an additional problem for the treatment, the analyst believes. The data "is far from inspiring confidence" and makes the outlook for aducanumab "more speculative than ever," Schimmer contended. LILLY: Also this morning, Eli Lilly presented results from a pre-specified secondary analysis of several Phase 3 studies at the Alzheimer's Association International Conference. According to the company, the results suggest the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were preserved at the primary time point of 108 weeks within a pre-defined margin. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were also preserved at an additional time point of 132 weeks within a pre-defined margin.The differences at 108 weeks and at at 132 weeks remained statistically significant, the company said. PRICE ACTION: In morning trading, Biogen fell 3% to $397.43 while Eli Lilly shares rose 0.6% to $86.11.
10:01 EDTBIIBOn The Fly: Analyst Downgrade Summary
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09:28 EDTBIIBBiogen downgraded to Neutral at Piper Jaffray after Alzheimer's data
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09:22 EDTBIIBBiogen downgraded to Neutral from Overweight at Piper Jaffray
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09:07 EDTBIIBOn The Fly: Pre-market Movers
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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07:19 EDTBIIBBiogen drops 4.8% to $390 after reporting Alzheimer's drug data
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.
06:50 EDTBIIBBiogen's Alzheimer's candidate shows reduction of clinical decline
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06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
12:47 EDTSNY, AMGNPiper 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.
11:49 EDTAMGNNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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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.
07:12 EDTAMGNAmgen's Repatha granted marketing authorization by EC
Amgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
06:24 EDTBIIBPiper expects 'stronger, bolder' move from Biogen
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06:12 EDTBIIBBiogen implied volatility of 50 at upper end of index
July 20, 2015
07:32 EDTBIIBAlzheimer's Association to hold a conference
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