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Stock Market & Financial Investment News

News Breaks
August 11, 2014
11:58 EDTSNY, LLY, MNKD, NVOMannKind 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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January 26, 2015
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 22, 2015
14:33 EDTNVONovo Nordisk receives positive opinion from CHMP for Saxenda
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNY, LLYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
11:56 EDTMNKDStocks with call strike movement; RIG MNKD
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January 16, 2015
16:00 EDTMNKDOptions Update; January 16, 2015
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January 15, 2015
11:20 EDTLLYGoldman cuts J&J to sell citing competitive pressures
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10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
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07:07 EDTLLYEli Lilly upgraded at Goldman
As previously reported, Goldman upgraded Eli Lilly to Neutral from Sell. The firm upgraded shares based on new product launches and pipeline assets, and cost reductions. Price target is $70.
06:44 EDTLLYEli Lilly upgraded to Neutral from Sell at Goldman
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05:53 EDTMNKDStocks with implied volatility movement; MNKD TSM
Stocks with implied volatility movement; MannKind (MNKD) 70, TSMC (TSM) 34 according to iVolatility.

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