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December 12, 2012
06:56 EDTLLYEli Lilly provides update on next steps for Solanezumab
Eli Lilly provided an update on the next steps planned for solanezumab, its Phase 3 monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase 3 study of solanezumab in patients with mild Alzheimer's disease. Additional details, including study design and length, are still being determined. Lilly expects to initiate this study no later than 3Q2013. Based on recent meetings with the FDA, Lilly does not intend to submit a Biologics License Application at this time in the U.S. based solely on the existing analyses of data from the Expedition studies. Lilly will continue to analyze and discuss the data from the two, Phase 3, double-blind, placebo-controlled solanezumab Expedition studies with regulators globally to determine the regulatory paths forward in different regions. It is possible that different courses of action could be taken in different jurisdictions.
News For LLY From The Last 14 Days
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October 6, 2015
05:23 EDTLLYEli Lilly, Adocia initiate Phase 1b study of BioChaperone Lispro
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October 1, 2015
10:37 EDTLLYBofA/Merrill's Top 10 US Ideas for Q4 2015
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September 30, 2015
06:16 EDTLLYEli Lilly volatility at 52-week highs
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05:41 EDTLLYEli Lilly, Adocia initiate new Phase 1b study evaluating BioChaperone Lispro
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September 29, 2015
09:27 EDTLLYOn The Fly: Pre-market Movers
HIGHER: Yahoo (YHOO), up 4.5% after the company's board authorized the company to continue to pursue its spin-off of Aabaco Holdings, a newly formed independent registered investment company that will hold all of Yahoo's remaining holdings in Alibaba Group (BABA)... Phoenix Companies (PNX), up 164% after Nassau Reinsurance agreed to acquire Phoenix for $37.50 per share in cash... McDonald's (MCD), up 1.4% after the stock was upgraded to Outperform at Credit Suisse... Johnson & Johnson (JNJ), up 1% following upgrade at Deutsche Bank. LOWER: Esperion (ESPR), down 29% after reporting that the FDA has encouraged the company to initiate a cardiovascular outcomes trial promptly since any concern regarding the benefit/risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval... Solera (SLH), down 2% after IHS (IHS) said on its earnings call that it is not pursuing an acquisition of the company, as previouly indicated in media reports... Zosano (ZSAN), down 54% after the company announced that it would discontinue its ZP-PTH agreement with Eli Lilly (LLY).
08:43 EDTLLYZosano Pharma price target lowered to $11 from $20 at Roth Capital
Roth Capital cut its price target on Zosano (ZSAN) after the company announced that it would discontinue its ZP-PTH agreement with Eli Lilly (LLY) in order to focus on a one time per week program. The firm expects Zosano's shares to drop significantly today, but it continues to expect the company's other programs to generate positive data. It keeps a Buy rating on the shares.
06:47 EDTLLYEli Lilly and Incyte's baricitinib Phase 3 study met primary objective
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September 28, 2015
19:11 EDTLLYOn The Fly: After Hours Movers
HIGHER: Yahoo (YHOO), up 3.3% after the board authorized Yahoo to continue to pursue the Aabaco spin-off plan... Cheniere Energy (LNG), up 0.67% after Carl Icahn raised his stake in the company to 11.43%... Republic Airways (RJET), up 7.4% after the company was upgraded to Buy from Hold at Deutsche Bank... Exelon (EXC) and Pepco (POM), higher by 1% and 2.4%, respectively, after the DC Mayor's office released a statement confirming discussions of a settlement agreement with the companies. LOWER AFTER EARNINGS: SYNNEX (SNX), down 2.7% after the company reported Q3 results, gave Q4 guidance, and raised its quarterly dividend. ALSO LOWER: Zosano (ZSAN), down 52.5% after it discontinued development of its Daily ZP-PTH treatment for severe osteoporosis and terminated a collaboration agreement with Eli Lilly (LLY)... OvaScience (OVAS), down 15.9% after the company announced it doesn't expect to meet its previous 2015 goal of 1,000 Augment treatment cycles.
09:35 EDTLLYEli Lilly and Sanofi reach settlement agreement in glargine litigation
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09:33 EDTLLYSanofi reaches patent settlement with Eli Lilly on Lantus
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08:04 EDTLLYEli Lilly announces study of Cyramza in combination met primary end
A Phase II study of Eli Lilly's CYRAMZA in combination with docetaxel met its primary endpoint, demonstrating a statistically significant increase in progression-free survival (PFS) for patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based therapy. Bladder cancer accounts for the vast majority of all urothelial carcinoma. Final results of the Phase II trial were presented at the European Cancer Congress (ECC2015) in Vienna, Austria on September 27. Based on these findings, Lilly recently initiated a Phase III trial called RANGE, which has begun to enroll patients. The three-arm trial evaluated 140 patients with advanced carcinoma of the urothelial tract who, after a first-line platinum-based chemotherapy regimen, had relapsed up to one year following the initial treatment. Patients were randomized to receive either a combination of ramucirumab and docetaxel, docetaxel alone (n=45), or a combination of icrucumab and docetaxel. Treatment continued until disease progression or toxicity levels resulted in an interruption of treatment with one or more of the study medicines.
07:38 EDTLLYBox to hold a user conference
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07:27 EDTLLYFDA and the Parental Drug Association to co-host a conference
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September 25, 2015
07:22 EDTLLYEuropean Society for Medical Oncology to hold a conference
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September 22, 2015
07:43 EDTLLYDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTLLYClinton to roll out plan to rein in prescription drug costs, USA Today reports
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