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News Breaks
March 5, 2014
09:34 EDTLLYFDA issues complete response letter for Empagliflozin to Boehringer, Lilly
Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company announced the U.S. Food and Drug Administration has issued a complete response letter for the New Drug Application of the investigational sodium glucose co-transporter-2 inhibitor empagliflozin.The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with type 2 diabetes and submitting a response to the complete response letter as soon as possible. The U.S. NDA was based on results from one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 people with type 2 diabetes.
News For LLY From The Last 14 Days
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June 26, 2015
07:34 EDTLLYEli Lilly volatility elevated as shares near record high
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05:17 EDTLLYEli Lilly, Adocia report positive Phase 1b topline results for BioChaperone Lisp
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June 25, 2015
10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: AT&T (T) upgraded to Buy from Neutral at BofA/Merrill... Eli Lilly (LLY) upgraded to Buy, added to US 1 List at BofA/Merrill... Finish Line (FINL) upgraded to Buy from Neutral at B. Riley... Gran Tierra (GTE) upgraded to Buy from Hold at Canaccord... Greenhill & Co. (GHL) upgraded to Buy from Sell at Goldman... Magnum Hunter (MHR) upgraded to Equalweight from Underweight at Capital One... Marathon Oil (MRO) upgraded to Buy from Neutral at UBS... Newpark Resources (NR) upgraded to Strong Buy from Outperform at Raymond James... Office Depot (ODP) upgraded to Outperform from Market Perform at Telsey Advisory... Quanex (NX) upgraded to Outperform from In-Line at Imperial Capital... Vestas Wind (VWDRY) upgraded to Outperform from Neutral at Exane BNP Paribas... Web.com (WWWW) upgraded to Buy from Neutral at B. Riley... NRG Yield upgraded to Outperform from Market Perform at Avondale.
07:39 EDTLLYEli Lilly upgraded to Buy, added to US 1 List at BofA/Merrill
As previously reported, BofA/Merrill upgraded Eli Lilly to Buy from Neutral and added it to the US 1 List. The firm raised estimates and increased its price target to $101 from $74 based on more bullish pipeline expectations. BofA/Merrill highlights eva and sola pipelines, which have high risk/reward opportunities with Phase III data in the next 12-18 months. Firm forecasts peak sales of $1.5B for eva and $2B for sola and said success in either of these programs would result in significant upside to estimates.
06:44 EDTLLYEli Lilly upgraded to Buy from Neutral at BofA/Merrill
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06:07 EDTLLYEli Lilly reports UK court rules in favor of Lilly in Alimta vitamin patent suit
Eli Lilly announced that the Court of Appeal has ruled that the Alimta vitamin regimen patent would be indirectly infringed by a generic competitor that had stated its intent to market certain alternative salt forms of pemetrexed in the United Kingdom prior to the UK patent's expiration in June 2021. Specifically, the Court of Appeal held that commercialization of these alternative salt forms in the products as proposed would constitute indirect infringement by supplying an essential means for putting the patented invention into effect. The decision came in the case of Actavis v. Eli Lilly and Company. The Court of Appeal also held there was no difference between the law in the UK and that in France, Italy and Spain as it relates to indirect infringement, and so reversed the High Court's decision granting declarations of noninfringement over the Alimta vitamin regimen patents in those countries. Actavis may seek permission to appeal the decision to the UK Supreme Court. In addition, Actavis has stated it may ask the High Court to decide whether a different proposed product would infringe the patent. The Court of Appeal has ruled that the High Court will need to decide whether it will hear this new claim. If the High Court decides to hear Actavis' case on the different proposed product, Lilly will defend the case vigorously. In Europe, the compound patents for Alimta remain in force and are expected to provide exclusivity through December 2015. This decision increases the likelihood that the vitamin regimen patents for Alimta will provide exclusivity in the UK, France, Italy and Spain through June 2021.
June 22, 2015
11:31 EDTLLYActinobac Biomed signs licensing agreemnt with Eli Lilly unit Elanco
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08:39 EDTLLYBernstein pharmaceuticals analyst holds an analyst/industry conference call
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June 19, 2015
10:34 EDTLLYEli Lilly to host conference call
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08:04 EDTLLYEli Lilly publishes results of Phase III REACH trial evaluating Cyramza
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07:23 EDTLLYTeva data quite strong, says Bernstein
After Teva (TEVA) announced data for its TEV-48125 drug in episodic migraine, Bernstein notes that the drug met its primary and secondary endpoints. The firm says that the reduction in migraine days of Teva's drug appears to be higher than what Amgen (AMGN) and Lilly (LLY) have shown. The firm continues to see the migraine treatments from Teva and Alder as better than those from Lilly and Amgen.
June 17, 2015
12:02 EDTLLYEli Lilly reports LY2951742 meets primary endpoint in Phase 2b migraine study
Eli Lilly announced that its investigational medicine for prevention of migraine -- LY2951742, a CGRP neutralizing antibody -- met the primary endpoint in a Phase 2b study in episodic migraine. The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of four different doses of LY2951742 given in a once-monthly, subcutaneous injection in more than 400 patients with episodic migraine. The primary objective was to assess whether at least one dose of LY2951742 was superior to placebo in the prevention of migraine headache. LY2951742 demonstrated a statistically significant reduction in migraine headache days and a safety and tolerability profile confirming the previous results seen in a Phase 2a study. In addition to the migraine program, Lilly has initiated two Phase 3 trials with LY2951742 in patients suffering from cluster headache. Based on the unmet medical need and significance of this disorder for patients, Lilly has been granted fast track designation from the U.S. FDA for cluster headache.
10:00 EDTLLYOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: AbbVie (ABBV) initiated with an Overweight at Piper Jaffray... Arista Networks (ANET) initiated with a Buy at Sterne Agee CRT... Astec (ASTE) initiated with a Buy at Maxim... Bristol-Myers (BMY) initiated with an Underweight at Piper Jaffray... Community Healthcare (CHCT) initiated with an Outperform at Oppenheimer... Eli Lilly (LLY) initiated with an Overweight at Piper Jaffray... Fitbit (FIT) initiated with a Buy ahead of IPO at Dougherty... Hortonworks (HDP) initiated with a Buy at Mizuho... II-VI (IIVI) initiated with a Buy at Benchmark Co.... J Sainsbury (JSAIY) initiated with an Underperform at Credit Suisse... McDermott (MDR) initiated with an Outperform at Cowen... Merck (MRK) initiated with a Neutral at Piper Jaffray... Molina Healthcare (MOH) initiated with a Buy at UBS... Pacific DataVision (PDVW) initiated with a Buy at Canaccord... Pfizer (PFE) initiated with an Overweight at Piper Jaffray... Quest Resource (QRHC) initiated with a Buy at Roth Capital... Regional Management (RM) initiated with a Buy at Janney Capital... Rofin-Sinar (RSTI) initiated with a Buy at Benchmark Co.... Salesforce (CRM) initiated with a Neutral at Exane BNP Paribas... Sprouts Farmers Markets (SFM) initiated with a Neutral at Cleveland Research... Tesco (TSCDY) initiated with an Underperform at Credit Suisse... WM Morrison (MRWSY) initiated with a Neutral at Credit Suisse... WWE (WWE) initiated with a Buy at BTIG... World Acceptance (WRLD) initiated with a Buy at Janney Capital... Zafgen (ZFGN) initiated with a Buy at SunTrust.
08:10 EDTLLYEli Lilly and Dana-Farber Cancer Institute enter research collaboration
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08:02 EDTLLYEli Lilly partnering with Sarah Cannon Research Institute for oncology therapy
Eli Lilly and Sarah Cannon Research Institute announced a strategic partnership to co‑develop an investigational oncology compound, LY3023414, a PI3K/mTOR dual inhibitor. Under the agreement, SCRI will collaborate with Lilly to provide clinical development expertise and program design, as well as medical oversight and trial management. Patient enrollment for the initial Phase II clinical trial is underway.
07:25 EDTLLYPiper calls Bristol 'modestly overvalued,' starts shares with sell
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05:31 EDTLLYEli Lilly initiated with an Overweight at Piper Jaffray
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June 16, 2015
08:36 EDTLLYEli Lilly price target raised to $100 from $87 at Jefferies
Jefferies raised its price target for Eli Lilly shares to $100 saying that while the market is "overly-obsessed" on the EXPEDITION-EXT abstract for Alzheimer's, the potential for cholesterol treatment evacetrapib should begin to be realized over the next 12 months. Jefferies keeps a Buy rating on Lilly.
June 15, 2015
10:26 EDTLLYOptions with increasing implied volatility
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09:19 EDTLLYBiotech Industry Organization to hold a conference
BIO 2015 is being held in Philadelphia on June 15-18.
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