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Stock Market & Financial Investment News

News Breaks
August 11, 2014
11:58 EDTMNKD, SNY, NVO, LLYMannKind rallies after inking licensing agreement with Sanofi
Shares of MannKind (MNKD), a development-stage biopharmaceutical company, are rallying after the company announced that it has formed an exclusive licensing agreement for the development and commercialization of Afrezza inhaled insulin with drug giant Sanofi (SNY). WHAT'S NEW: MannKind and Sanofi this morning said they would develop and commercialize Afrezza for adults with diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015. Under the terms of the agreement, MannKind will receive an upfront payment of $150M and potential milestone payments of up to $775M. Sanofi will be responsible for global commercial, regulatory and development activities, while MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. The companies are also planning to collaborate to expand manufacturing capacity to meet global demand as necessary. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration's expenses up to a limit of $175M, the companies said. WHAT'S NOTABLE: MannKind also reported its second quarter earnings this morning. Second quarter losses per share were (19c), missing analysts' consensus expectation of (12c). Total operating expenses for the quarter were $69.8M versus $41.6M in the year-ago period and research and development expenses increased by $10.2M to $37.3M compared to the same quarter in 2013. ANALYST REACTION: Piper Jaffray, which has a Neutral rating on MannKind shares, views the Sanofi partnership as "impressive" given the "meaningful" upfront payment, shared economics and an advance of expenses. Piper believes investors will view the partnership and terms favorably. PRICE ACTION: Near noon, MannKind shares were up 91c, or 11%, to $9.04, while Sanofi shares were up 7c, or 0.1%, to $52.39. OTHERS TO WATCH: Novo Nordisk (NVO) and Eli Lilly (LLY) also make fast-acting insulin.
News For MNKD;SNY;NVO;LLY From The Last 14 Days
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September 24, 2014
17:01 EDTSNY, MNKDMannKind announces closing of global licensing agreement with Sanofi
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08:10 EDTSNYSanofi unit announces research collaboration
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September 23, 2014
09:00 EDTLLY, SNYBofa/Merill special situations team to hold an analyst/industry conference call
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September 22, 2014
07:21 EDTSNY, LLYEBD Group to hold a conference
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September 18, 2014
15:57 EDTLLYFDA approves Trulicity with boxed warning, post-marketing study requirements
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15:55 EDTLLYFDA approves Eli Lilly type 2 diabetes drug
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14:20 EDTNVONovo Nordisk announces EC marketing authorisation for Xultophy
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13:13 EDTNVONovo Nordisk Ryzodeg does not meet primary endpoint in phase 3b trial
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11:15 EDTLLYRepros sinks after panel backs tests for testosterone therapies
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08:12 EDTLLYEli Lilly's Cyramza for gastric cancer shows positive Phase 3 results
Eli Lilly announced results of the global Phase III trial of ramucirumab - CYRAMZA - in combination with paclitaxel in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma. The addition of ramucirumab to paclitaxel showed a statistically significant improvement in median overall survival, meeting its primary endpoint; it also met secondary endpoints of progression-free survival and objective response rate. Data from the trial were first presented in January. Ramucirumab has now been the focus of two positive Phase III gastric cancer trials that have demonstrated statistically significant improvements in both overall survival and progression-free survival.
08:01 EDTLLYDow AgroSciences announces R&D agreement with Lilly's Elanco
Two Indiana agricultural companies, Elanco, the animal health division of Eli Lilly and Company (LLY), and Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company (DOW), are announcing a strategic research and development agreement that will focus on developing integrated solutions to enable livestock producers to increase meat and milk production to meet the demands of the growing global population.
06:10 EDTLLYFDA panel votes 20-1 to study changes to testosterone therapies
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September 17, 2014
07:39 EDTLLYMorningstar to hold a conference
Management Behind the Moat Conference to be held in Chicago on September 17-18.
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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05:51 EDTMNKDStocks with implied volatility movement; OREX MNKD
Stocks with implied volatility movement; Orexigen (OREX) 91, MannKind (MNKD) 60 according to iVolatility.
September 16, 2014
12:35 EDTLLYDenovo Biopharma acquires late-stage oncology drug enzastaurin from Eli Lilly
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07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTNVO, LLYEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:02 EDTLLYEli Lilly and AstraZeneca to co-develop and commercialize AZD3293
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06:27 EDTLLYAstraZeneca, Eli Lilly to jointly develop, commercialize AZD3293
AstraZeneca (AZN) and Eli Lilly (LLY) announced an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in development as a potential treatment for Alzheimer's disease. AZD3293 has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500M in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50M in the 1H15. The companies will share all future costs equally for the development and commercialization of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer's disease. Lilly will lead clinical development, working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of AZD3293. The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca's 2014 Core Earnings per Share.
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