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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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October 21, 2014
07:06 EDTSNYFierce Biotech to hold a breakfast meeting
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06:44 EDTSNYActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the productís U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
08:06 EDTSNYMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:19 EDTSNYIBC Life Sciences to hold a conference
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07:10 EDTSNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
06:52 EDTMNKDMannKind initiated with a Neutral at Goldman
Target $6.
October 17, 2014
10:51 EDTLLYOptions with increasing implied volatility
Options with increasing implied volatility: COV DISH HLT QEP GREK BKW BYI LLY DTV TIBX
09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
October 16, 2014
14:36 EDTLLYLilly to close Guayama facility, will take 16c charge in Q4
Eli Lilly announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. All of the approximately 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina, Puerto Rico, location. As a result of this action, the company expects to record a charge of approximately $170M or approximately 16c per share, after tax, in Q414. While Lilly will initiate efforts to sell the Guayama site, the company will continue to invest in two manufacturing plants at Carolina. In November 2013, Lilly announced a $200M investment to increase capacity in its Carolina-based insulin active ingredient manufacturing plant. In July, Lilly announced an additional $40M in investments to increase capabilities at its Carolina-based drug product site as part of a rebalancing of Lilly's oral solid dosage network.
08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
October 15, 2014
10:02 EDTSNYOn The Fly: Analyst Upgrade Summary
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07:29 EDTSNYSelecta, JDRF, Sanofi extend collaboration for SVP immunotherapy
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05:26 EDTSNYSanofi upgraded to Outperform from Neutral at Credit Suisse
October 14, 2014
11:23 EDTSNY, NVOBIND Therapeutics and The Conference Forum hold a conference
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09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
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08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
07:15 EDTLLYBiotech Industry Organization to hold a summit
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October 10, 2014
10:03 EDTLLYEli Lilly olaratumab granted orphan designation as soft tissue sarcoma treatment
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