Key Developments: Eli Lilly and Co (LLY.N)

LLY.N on New York Stock Exchange

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21 Nov 2014
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Latest Key Developments (Source: Significant Developments)

Eli Lilly and Company CYRAMZA (ramucirumab) in Combination with Paclitaxel GRANTED FDA approval for Advanced Gastric Cancer after prior chemotherapy
Wednesday, 5 Nov 2014 02:49pm EST 

Eli Lilly and Company:Says that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA(ramucirumab) in combination with paclitaxel (a type of chemotherapy).As a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.This FDA approval for CYRAMZA is based on the Phase III RAINBOW trial, which compared CYRAMZA plus paclitaxel to placebo plus paclitaxel.Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate.  Full Article

Eli Lilly and Company announces dividend payment
Tuesday, 4 Nov 2014 07:00pm EST 

Eli Lilly and Company:Decided to proceed with the cash dividend distribution on the ordinary shares.Says the ex-date is Nov. 12.Says the record date is Nov. 11.Says the payment date is Dec. 12.Says the gross dividend is $0.49.  Full Article

Virbac to acquire United States veterinary assets from Eli Lilly
Monday, 27 Oct 2014 02:33am EDT 

Virbac SA:Agrees to acquire veterinary assets from Eli Lilly in United States.Says deal is for veterinary products marketed by Novartis Animal Health.Says assets to be acquired are related to two parasiticides for dogs, namely Sentinel Flavor Tabs and Sentinel Spectrum.Says deal is subject to approval by Federal Trade Commission and conditioned on closing of acquisition of Novartis Animal Health by Eli Lilly.  Full Article

Eli Lilly and Co reaffirms FY 2014 earnings outlook; lowers high end of prior FY 2014 revenue outlook to a range in line with analysts' estimates
Thursday, 23 Oct 2014 06:31am EDT 

Eli Lilly and Co:Expects FY 2014 earnings per share to be in the range of $2.34 to $2.42 on a reported basis, as compared to previous range of $2.67-$2.75.Expects FY 2014 earnings per share to be in the range of $2.72 to $2.80 on a non-GAAP basis, as compared to previous range of $2.72-$2.80.Expects FY 2014 net income to be at least $2.6 bln on a reported basis, as compared to previous range of $2.9 bln.Says it still FY 2014 net income to be at least $2.9 bln on a non-GAAP basis.Expects FY 2014 revenue in the range of $19.4 to $19.8 bln, as compared to previous range of $19.4 to $20.0 bln.FY 2014 EPS of $2.75, net income of $2.9 bln, revenue of $19.7 bln - Thomson Reuters I/B/E/S.  Full Article

CANDA NK-2 files motion to dismiss patent infringement suit originally filed by Eli Lilly and Company
Wednesday, 22 Oct 2014 05:45pm EDT 

CANDA NK-2, LLC, subsidiary of CANDA Pharma, LLC:Says the company has moved to dismiss a patent infringement lawsuit, based on lack of personal jurisdictions over the defendants.Says the claim was originally filed on Oct. 8, by Eli Lilly and Company in the United States District Court for the Southern District of Indiana.Says the motion to dismiss was filed in partnership with Nang Kuang Pharmaceutical Co., LTD., by Farney Daniels, PC, counsel for the defendants.Says lawsuit alleges that Nang Kuang infringed U.S. Patent Nos. 5,344,932 and 7,772,209 by submitting an Abbreviated New Drug Application to the U.S. Food & Drug Administration (FDA) requesting approval of a generic pemetrexed disodium, 100 mg base/vial and 500 mg base/vial for intravenous infusion.Says the pharmaceuticals are chemotherapy agents used for the treatment of various types of cancer.Case is Eli Lilly and Company v. Nang Kuang Pharmaceutical and CANDA NK-2, No. 1:14-cv-1647.  Full Article

Eli Lilly and co and Zymeworks Inc announces expansion of strategic licensing and collaboration agreement
Wednesday, 22 Oct 2014 04:15pm EDT 

Eli Lilly and co and Zymeworks Inc:Says the expansion of their existing licensing and collaboration agreement.Says on Oct. 22, Lilly is opting to expand the collaboration by up to potentially $375 mln in milestones and other payments.Plus tiered sales royalties based on country-by-country intellectual property, and sales to include development of several immuno-modulatory bi-specific antibodies against multiple targets.Zymeworks will receive an initial up-front payment in the form of an equity investment, which will strengthen the strategic relationship between the two companies.Further financial terms were not disclosed.  Full Article

Eli Lilly and Co declares fourth-quarter 2014 dividend
Monday, 20 Oct 2014 04:10pm EDT 

Eli Lilly and Co:Declares dividend for the fourth quarter of 2014 of $0.49 per share on outstanding common stock.Payable Dec. 10 to shareholders of record at the close of business on Nov. 14.  Full Article

Eli Lilly and Company gives Q4 2014 charge outlook
Thursday, 16 Oct 2014 02:29pm EDT 

Eli Lilly and Company:Expects to record a charge of about $170 million (pre-tax) or about $0.16 per share (after tax) in Q4 2014.  Full Article

Eli Lilly and Company announces plan to realign Puerto Rico manufacturing operations
Thursday, 16 Oct 2014 02:29pm EDT 

Eli Lilly and Company:Plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico.Says manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015.All of the about 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina (Puerto Rico) location.  Full Article

Eli Lilly and Co to discontinue development of Tabalumab Based on Efficacy Results in Phase 3 Lupus Studies
Thursday, 2 Oct 2014 08:30am EDT 

Eli Lilly and Co:Says it will discontinue development of tabalumab- -- being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus) -- due to insufficient efficacy in two pivotal Phase 3 trials.Says the decision was not based on safety concerns.Says in the illuminate 1 study, tabalumab did not achieve the primary endpoint, at either dose studied, of statistically significant improvement on SRI-5 (SLE Responder Index-5, a measurement of lupus disease activity and response), compared to standard of care therapy.Says in ILLUMINATE 2, the higher dose of tabalumab met this endpoint, the first time a lupus study has achieved this efficacy measure as a primary endpoint in a Phase 3 trial.Says collectively, the data from these studies did not meet expectations for efficacy in the context of existing treatments.Says overall safety profile showed a similar frequency of adverse events in patients treated with either tabalumab or standard of care. Lilly intends to submit these data for disclosure in appropriate upcoming scientific venues.Says given the overall efficacy results from these two pivotal Phase 3 studies, it will not move forward with submissions to global regulators.Says it will work with investigators to appropriately conclude these studies in the interest of patient safety.  Full Article

Lilly, Boehringer revise terms of diabetes drugs alliance

- Eli Lilly and Co and German drugmaker Boehringer Ingelheim said they had revised the structure of their diabetes alliance for some countries.

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