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June 16, 2014
18:19 EDTLLYEli Lilly reports results from Phase 3 trials of Dulaglutide
Eli Lilly and Company released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia. Dulaglutide is an investigational glucagon-like peptide-1 receptor agonist being studied for the treatment of type 2 diabetes. Results were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco. "Many patients with type 2 diabetes reach a point when oral medicines alone may no longer be effective enough. In these cases, many healthcare professionals choose to intensify treatment with an injectable medicine," said Francesco Giorgino, MD, professor of endocrinology and metabolism, University of Bari, Italy. "Data from these two studies comparing once-weekly dulaglutide with insulin glargine, in combination with other diabetes treatments, provide important information about a GLP-1 receptor agonist that, if approved, may be appropriate for patients with type 2 diabetes." Results from the AWARD-2 trial, which evaluated the safety and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated patients reached target HbA1c levels of less than 7 percent. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels. Both doses of dulaglutide were associated with sustained weight loss, while insulin glargine showed weight gain. Results from the AWARD-4 trial the first Phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin showed that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7%, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30% less total insulin dose. Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with relative weight benefit compared to the basal/bolus therapy of insulin glargine and mealtime insulin lispro. Hypoglycemia rates were lower in dulaglutide 1.5 mg-treated patients compared to insulin glargine in both studies. In AWARD-2, the 0.75 mg dose also had a lower rate of hypoglycemia compared to insulin glargine. Adverse events were similar for dulaglutide-treated patients in both studies. The most frequently reported events were gastrointestinal-related, including nausea, diarrhea and vomiting. Nausea, which was mostly mild to moderate, was the most commonly reported event. These findings are consistent with prior studies of once-weekly dulaglutide.
News For LLY From The Last 14 Days
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August 4, 2015
17:11 EDTLLYEli Lilly to end contract University of California, San Diego
Eli Lilly and Company notified the University of California, San Diego of its intent to end its contract with the university for the management of the anti-amyloid treatment in Asymptomatic Alzheimer's disease, or A4, study. The A4 study is a novel clinical trial testing solanezumab in the preclinical stage of Alzheimer's disease in older individuals who have evidence of amyloid in their brains on a PET scan, but do not show symptoms of memory impairment. A4 has been managed by the Alzheimer's Disease Cooperative Study at UCSD. Lilly, the National Institutes of Health and multiple philanthropic organizations fund the study.
11:30 EDTLLYCVS drops Viagra from drug coverage list, Bloomberg reports
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July 31, 2015
14:08 EDTLLYEli Lilly removed from short-term buy list at Deutsche Bank
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July 27, 2015
08:08 EDTLLYEli Lilly accepts recommendation to continue Phase 3 trial of evacetrapib
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July 24, 2015
09:33 EDTLLYEli Lilly weakness creates buying opportunity, says Argus
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July 23, 2015
10:08 EDTLLYOptions with decreasing implied volatility
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08:43 EDTLLYEli Lilly Alzheimer's data positive, says SunTrust
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06:48 EDTLLYEli Lilly up 5.5% after reporting Q2 results, raising FY15 guidance
06:37 EDTLLYEli Lilly expands San Diego biotechnology center
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06:33 EDTLLYEli Lilly raises FY15 EPS view to $3.20-$3.30 from $3.10-$3.20, consensus $3.18
Narrows FY15 revenue guidance to $19.7B-$20B from $19.5B-$20B, consensus $19.8B.
06:30 EDTLLYEli Lilly reports Q2 adjusted EPS 90c, consensus 74c
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July 22, 2015
15:26 EDTLLYNotable companies reporting before tomorrow's open
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10:59 EDTLLYBiogen 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.
10:05 EDTLLYEli Lilly gaps down, retraces, levels to watch
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08:40 EDTLLYEli Lilly July weekly volatility elevated into Q2 and Alzheimer's drug data
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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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