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

LLY.N on New York Stock Exchange

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31 Mar 2015
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Latest Key Developments (Source: Significant Developments)

Pfizer Inc and Eli Lilly and Co preparing to resume phase 3 chronic pain program for Tanezumab
Monday, 23 Mar 2015 08:00am EDT 

Pfizer Inc adn Eli Lilly and Co:Says that they are preparing to resume Phase 3 clinical program for Tanezumab.As a result, Pfizer expects to receive $200 mln upfront payment from Lilly in accordance with their collaboration agreement.Says this announcement follows decision by U.S. Food and Drug Administration (FDA) to lift partial clinical hold on tanezumab development program after review of robust body of nonclinical data characterizing sympathetic nervous system response to tanezumab.Says data were submitted to FDA in Feb. 2015.In prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines.Says partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since Dec. 2012 due to adverse changes in the sympathetic nervous system of mature animals.Studies in terminal cancer pain were allowed to proceed.  Full Article

Eli Lilly and Co and Innovent Biologics Inc announce strategic alliance
Friday, 20 Mar 2015 08:00am EDT 

Eli Lilly and Co and Innovent Biologics Inc:Will collaborate to support the development and potential commercialization of at least three cancer treatments.Innovent will lead the development and manufacturing for the China market, while Lilly will be responsible for commercialization of the three potential medicines. Innovent also has co-promotion rights.  Full Article

Eli Lilly and Co and Hanmi Pharmaceutical Co Ltd announce an exclusive license and collaboration agreement
Thursday, 19 Mar 2015 08:00am EDT 

Eli Lilly and Co and Hanmi Pharmaceutical Co Ltd:Have entered into an exclusive license and collaboration agreement for the development and commercialization of Hanmi's oral Bruton's tyrosine kinase (BTK) inhibitor, HM71224, for the treatment of autoimmune and other diseases.Says agreement is subject to clearance under Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside U.S., and other customary closing conditions.Under terms of agreement, Lilly will receive worldwide rights to molecule for all indications excluding China, Hong Kong, Taiwan, and Korea.Lilly will take development, regulatory, manufacturing, and commercial leadership for molecule in Lilly territories.Hanmi will receive an initial payment of $50 mln and is eligible for up to $640 mln in potential development, regulatory, and sales milestones.If BTK inhibitor is successfully commercialized, Hanmi would also be eligible for tiered double-digit royalty payments.  Full Article

Eli Lilly and Co loses Alimta drug patent case in Germany to Actavis - Reuters
Friday, 6 Mar 2015 09:39am EST 

Eli Lilly and Co:Has lost a patent case in Germany over its Alimta lung cancer drug to generic producer Actavis, hitting the company's future sales hopes for the medicine - Reuters.The German appeal court ruled that Actavis would not infringe patents held by Lilly if it marketed an alternative salt form of the drug, known generically as pemetrexed, once the compound patent expires in Dec 2015.The ruling contradicts a previous verdict by a lower court in Germany and Lilly's general counsel, Michael Harrington, said the company would fight the decision.  Full Article

Eli Lilly and Co and Incyte Corp announces update on second consecutive phase 3 trial in rheumatoid arthritis
Monday, 23 Feb 2015 07:00am EST 

Eli Lilly and Co and Incyte Corp:Says that investigational medicine baricitinib demonstrated a statistically significant improvement compared to placebo in a second consecutive phase 3 trial in rheumatoid arthritis.Says RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug (cDMARD).Says study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment.Says part of an extensive phase 3 program testing baricitinib in more than 3,000 patients at different stages along the RA treatment continuum.RA-BUILD study enrolled 684 patients with rheumatoid arthritis who previously had an inadequate response to, or were intolerant of, at least one cDMARD and had not received a biologic disease-modifying antirheumatic drug (bDMARD).Says patients received either one of two doses of once-daily baricitinib or placebo, in addition to their background therapy.  Full Article

Eli Lilly and Co provides update on Evacetrapib Phase 3 Trial
Thursday, 19 Feb 2015 08:00am EST 

Eli Lilly and Co:Says it has accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, to extend the Phase 3 trial of the investigational medicine evacetrapib by about six months.Says the decision is not based on any data from ACCELERATE, as both the academic committee and the company remain blinded to efficacy results.Says as part of the study extension, a futility analysis previously anticipated in Q1 2015 is now expected to occur in Q3 2015.  Full Article

Eli Lilly and Co reaffirms FY 2015 EPS outlook; lowers FY 2015 revenue outlook
Friday, 30 Jan 2015 06:25am EST 

Eli Lilly and Co:Confirmed FY 2015 EPS guidance in the range of $2.40 to $2.50 (reported), or $3.10 to $3.20 (non-GAAP).Revised FY 2015 revenue guidance in the range of $19.5 to $20.0 bln, as compared to previous range of $20.3 to $20.8 bln.FY 2015 EPS of $3.18, revenue of $20.6 bln - Thomson Reuters I/B/E/S.  Full Article

Eli Lilly and Co announces dividend
Friday, 30 Jan 2015 06:25am EST 

Eli Lilly and Co:Announces dividend for the first quarter of 2015 of $0.50 per share on outstanding common stock representing a 2 pct increase.Annual indicated rate is $2.00 per share.  Full Article

Eli Lilly and Co announces cash dividend distribution date
Friday, 16 Jan 2015 01:16pm EST 

Eli Lilly and Co:Decides to proceed to the cash dividend distribution on the ordinary shares.Ex date Feb. 11.Record date Feb. 13.Payment date March 10.Gross dividend $0.5 per share.Paying agency BNP PARIBAS SECURITIES SERVICES (030).  Full Article

Bristol-Myers Squibb Co and Eli Lilly and Co enter clinical collaboration
Tuesday, 13 Jan 2015 08:00am EST 

Bristol-Myers Squibb Co and Eli Lilly and Co:Says a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299).The Phase 1/2 trial will evaluate the investigational combination of Opdivo and galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and non-small cell lung cancer.The study will be conducted by Lilly. Additional details of the collaboration were not disclosed.  Full Article

FDA recommends no changes to Lilly's schizophrenia injection use

- The U.S. Food and Drug Administration said it would not recommend changes to the prescribing or use of Eli Lilly and Co's schizophrenia drug after a review of two deaths.

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