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News Breaks
April 8, 2014
08:39 EDTTKPYY, LLYTakeda to challenge award of $6B in punitive damages, Lilly ordered to pay $3B
Takeda Pharmaceuticals (TKPYY) announced last night that in the case of Terrence Allen, et al. v. Takeda Pharmaceuticals North America the jury found in favor of the plaintiffs and awarded $1.475M in compensatory damages. The allocation of liability was 75% Takeda and 25% Eli Lilly (LLY). The jury also awarded $6B in punitive damages from Takeda and $3B from co-defendant, Eli Lilly. “Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal. We have empathy for the Allens, but we believe the evidence did not support a finding that ACTOS caused his bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to ACTOS,” said Kenneth Greisman, senior vice president, general counsel, Takeda. Reference Link
News For TKPYY;LLY From The Last 14 Days
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February 8, 2016
06:28 EDTLLYPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 4, 2016
08:05 EDTTKPYYSeattle Genetics to receive $20M milestone payment under ADCETRIS collaboration
Seattle Genetics (SGEN) announced that it will receive a one-time $20M milestone payment under its ADCETRIS collaboration with Takeda Pharmaceutical Company Limited (TKPYY). The milestone was triggered by Takeda surpassing annual ADCETRIS net sales of $200M in its territory during 2015. The milestone will be recognized as royalty revenue in the first quarter of 2016. In addition, the company announced that the European Commission recently approved a Type II variation that includes data on the retreatment of adult patients with relapsed or refractory Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma who previously responded to ADCETRIS and who later relapse. The label update follows a positive opinion from the Committee for Medicinal Products for Human Use in October 2015.
05:17 EDTTKPYYTakeda announces FDA PDAC supports effectiveness of Brintellix
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February 3, 2016
07:32 EDTTKPYYTaked, Mersana Therapeutics expand partnership for XMT-1522
Mersana Therapeutics and Takeda Pharmaceutical announced that they have entered a new strategic partnership granting Takeda rights to Mersana's lead product candidate, XMT-1522, outside the United States and Canada. The deal also expands an existing collaboration between the companies to provide Takeda with additional access to Mersana's Fleximer antibody-drug conjugate platform and grants Mersana an option at the end of Phase 1 to co-develop and co-commercialize one of these programs in the United States. In addition, the companies will co-develop new payloads for use with ADCs. XMT-1522 is an investigational, Fleximer-based ADC therapy that targets HER2-expressing tumors, including breast, gastric and non-small cell lung cancers. Preclinical data suggest that XMT-1522 may have anti-tumor activity in patients with HER2 low-expressing cancers as well as in patients with HER2 high-expressing cancers that do not respond to currently available HER2-targeting therapies. Mersana anticipates filing an Investigational New Drug application for XMT-1522 with the U.S. Food and Drug Administration in mid-2016. Takeda and Mersana will co-develop XMT-1522, and Mersana will lead execution of the Phase 1 trial. Mersana will retain full commercial rights in the United States and Canada while Takeda will have rights in rest of world. Beyond development and commercialization of XMT-1522, the expanded partnership also grants Takeda access to additional targets within Mersana's Fleximer-based ADC platform, with Mersana retaining the right to select one program at the end of Phase 1 for co-development and co-commercialization in the United States. Takeda and Mersana will also work together, leveraging Takeda's proprietary small molecule libraries, to identify and develop novel payloads that both parties will be able to use in new ADC therapies. Takeda signed agreements with Mersana through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc., under which, Mersana will receive an upfront payment of $40 million and an additional payment of $20 million upon clearance of the IND for XMT-1522 by the FDA. Subject to the success of the XMT-1522 and ADC programs, Mersana is eligible to receive milestone payments of more than $750 million combined, as well as royalties. Takeda will also invest up to $20 million in equity in future rounds of Mersana financing.
07:17 EDTTKPYYFDA Psychopharmacologic Drugs Advisory Committee to hold a meeting
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February 1, 2016
06:18 EDTLLYTransition Therapeutics announces results from Phase 2 clinical study of TT401
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06:11 EDTLLYTransition Therapeutics reports results from Phase 2 clinical study of TT401
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January 29, 2016
05:20 EDTLLYEli Lilly, Adocia initiate Phase 1b study of BioChaperone Lispro U100
Adocia and Eli Lilly announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia's proprietary technology, BioChaperone, which is designed to enable the acceleration of insulin absorption. The study, under the Adocia-Lilly partnership, aims to compare the pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro to that of Humalog in 15 healthy Japanese subjects placed under euglycemic clamp.
January 28, 2016
09:55 EDTLLYEli Lilly nears test of key support at $80 area
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06:29 EDTLLYEli Lilly backs FY16 adjusted EPS view of $3.45-$3.55, consensus $3.54
Backs FY16 revenue guidance of $20.2B-$20.7B, consensus $20.83B.
06:27 EDTLLYEli Lilly reports Q4 EPS 78c, consensus 78c
Reports Q4 revenue $5.38B, consensus $5.32B.
January 27, 2016
14:44 EDTLLYEli Lilly volatility elevated into Q4 and outlook
Eli Lilly January weekly call option implied volatility is at 54, February is at 29; compared to its 52-week range of 15 to 41, suggesting large near term price movement into the expected release of Q4 results on January 28.
14:34 EDTLLYNotable companies reporting before tomorrow's open
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12:01 EDTTKPYYTakeda says FDA approves Dexilant SoluTab
Takeda Pharmaceuticals U.S.A. announced that the FDA approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease and the maintenance of healed erosive esophagitis and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release technology that is designed to provide two separate releases of medication.
09:02 EDTLLYEli Lilly and Roche to collaborate on Alzheimer's diagnostic tool
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January 25, 2016
08:36 EDTLLYFDA accepts supplemental NDA for Eli Lilly and Boehringer's Jardiance
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