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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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July 24, 2015
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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July 23, 2015
10:08 EDTLLYOptions with decreasing implied volatility
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08:43 EDTLLYEli Lilly Alzheimer's data positive, says SunTrust
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06:48 EDTLLYEli Lilly up 5.5% after reporting Q2 results, raising FY15 guidance
06:37 EDTLLYEli Lilly expands San Diego biotechnology center
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06:33 EDTLLYEli Lilly raises FY15 EPS view to $3.20-$3.30 from $3.10-$3.20, consensus $3.18
Narrows FY15 revenue guidance to $19.7B-$20B from $19.5B-$20B, consensus $19.8B.
06:30 EDTLLYEli Lilly reports Q2 adjusted EPS 90c, consensus 74c
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July 22, 2015
15:26 EDTLLYNotable companies reporting before tomorrow's open
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10:59 EDTLLYBiogen drops after reporting data on Alzheimer's drug
The shares of Biogen (BIIB) are falling after the company released data on its Alzheimer's treatment candidate, aducanumab. Peer Eli Lilly (LLY) also reported data this morning on its own experimental Alzheimer's drug, solanezumab. BIOGEN: Biogen's data "does not inspire confidence," Piper analyst Joshua Schimmer wrote in a note to investors today. The 6 mg dose of the drug performed similarly to the 1mg dose, and was barely better than the placebo, the analyst stated. The cognitive and functional performance of the patients who took the 6 mg dose did not improve by a statistically significant amount, while the results of patients taking the other doses were "noisy,"Schimmer stated. Additionally, indications of excess fluid in the brain was observed in a significant number of patients, representing an additional problem for the treatment, the analyst believes. The data "is far from inspiring confidence" and makes the outlook for aducanumab "more speculative than ever," Schimmer contended. LILLY: Also this morning, Eli Lilly presented results from a pre-specified secondary analysis of several Phase 3 studies at the Alzheimer's Association International Conference. According to the company, the results suggest the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were preserved at the primary time point of 108 weeks within a pre-defined margin. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were also preserved at an additional time point of 132 weeks within a pre-defined margin.The differences at 108 weeks and at at 132 weeks remained statistically significant, the company said. PRICE ACTION: In morning trading, Biogen fell 3% to $397.43 while Eli Lilly shares rose 0.6% to $86.11.
10:05 EDTLLYEli Lilly gaps down, retraces, levels to watch
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08:40 EDTLLYEli Lilly July weekly volatility elevated into Q2 and Alzheimer's drug data
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07:18 EDTLLYEli Lilly drops 3% to $83 after reporting Alzheimer's drug data
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07:06 EDTLLYEli Lilly's solanezumab for Alzheimer's supports 'delayed-start' use
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July 21, 2015
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
July 20, 2015
07:32 EDTLLYAlzheimer's Association to hold a conference
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July 16, 2015
11:57 EDTNVONovo Nordisk receives FDA approval for FlexPro PenMate
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05:46 EDTMNKDStocks with implied volatility movement; NFLX MNKD
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July 15, 2015
10:01 EDTLLYOn The Fly: Analyst Downgrade Summary
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06:37 EDTLLYEli Lilly downgraded to Equal Weight from Overweight at Morgan Stanley
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