New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 14, 2012
08:07 EDTMRK, ARIAEMA says Merck withdraws application for Jenzyl
The European Medicines Agency said on November 27 Merck Sharp & Dohme (MRK) officially notified the Committee for Medicinal Products for Human Use, or CHMP, that it wishes to withdraw its application for a marketing authorization for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy. Jenzyl is the trade name for ridaforolimus, which is being co-developed by Merck and ARIAD Pharmaceuticals (ARIA). Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma, a type of cancer that affects the soft, supporting tissues of the body, or bone sarcoma that have spread to other parts of the body. The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions. The company had not yet responded to the last round of questions at the time of the withdrawal. Based on the review of the data and the company’s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy, the CHMP said.
News For ARIA;MRK From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 5, 2015
08:15 EDTMRKMerck announces results of post-hoc analyses of TIMI 50 study
Merck, known as MSD outside the United States and Canada, announced results from post-hoc analyses of the TRA 2°P TIMI 50 -- Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events -- trial of ZONTIVITY, vorapaxar. Among the 3,787 patients whose qualifying diagnosis for the TRA 2°P TIMI 50 trial was symptomatic PAD including 514 patients with a history of stroke or TIA in whom use of ZONTIVITY is contraindicated, a total of 109 ALI events occurred during the trial. In this post-hoc subgroup analysis, researchers found that in patients with symptomatic PAD, adding ZONTIVITY to standard care which included aspirin and/or clopidogrel yielded a 42% relative risk reduction in the incidence of ALI versus aspirin and/or clopidogrel alone. In another post-hoc subgroup analysis of 5,845 patients in TRA 2ºP with a history of PAD regardless of primary enrollment stratum, ZONTIVITY vs. placebo, added to aspirin and/or clopidogrel, showed a consistent pattern of reduction in the need for peripheral revascularization among the various indications for PR captured by the analysis. Adding ZONTIVITY also reduced the rate of surgical PR procedures. Approximately 20% of the 5,845 patients included in this analysis had a history of stroke or TIA, which are contraindications to use of ZONTIVITY. In another post-hoc subgroup analysis of 2,942 post-MI or PAD patients with no history of stroke or TIA who had undergone coronary artery bypass grafting prior to the trial, adding ZONTIVITY to aspirin and/or clopidogrel reduced the risk of CV death, myocardial infarction or stroke; event rate 11.9% for ZONTIVITY vs. 15.6% for placebo. In these patients, ZONTIVITY increased the risk of GUSTO moderate or severe bleeding. In another subgroup analysis, among 319 post-MI or PAD patients with no history of stroke or TIA who underwent a new CABG during the trial, the rates of TIMI major bleeding within 30 days of surgery were 6% for ZONTIVITY and 4.2% for placebo.
March 4, 2015
18:34 EDTMRKMerck, Eisai enter clinical trial collaboration to test safety of KEYTRUDA
Subscribe for More Information
February 26, 2015
15:20 EDTMRKMerck says GARDASIL 9 recommended by CDC advisory committee
Subscribe for More Information
10:56 EDTARIAOptions with increasing implied volatility
Subscribe for More Information
09:41 EDTMRKHospira launches generic Remicade, WSJ says
Subscribe for More Information
February 25, 2015
08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2ºP studies
Subscribe for More Information
February 24, 2015
10:12 EDTARIAOptions with increasing implied volatility: LO ARIA OWW
05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
Subscribe for More Information
February 23, 2015
10:45 EDTARIAOptions with increasing implied volatility
Subscribe for More Information
08:27 EDTMRKNGM Biopharmaceuticals to hold a teleconference
NGM Biopharm discusses the strategic collaboration with Merck to discover, develop and commercialize novel biologic therapeutics on a teleconference to be held on February 23 at 9:30 am. Webcast Link
07:04 EDTMRKMerck, NGM Biopharmaceuticals announce multi-year collaboration
NGM Biopharmaceuticals and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck will make an upfront payment to NGM of $94M and will purchase a 15 percent equity stake in NGM for $106M at a price per share that represents a 20% premium to NGM’s most recent financing. Merck will commit up to $250M to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.
05:46 EDTARIAStocks with implied volatility movement; ARIA CYBR
Subscribe for More Information
February 20, 2015
07:08 EDTMRKAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
06:35 EDTARIASarissa Capital seeks retirement of ARIAD CEO, board seats
Sarissa Capital disclosed in a regulatory filing that it has been in negotiations with members of ARIAD's board in an attempt to avoid a potential proxy contest. Sarissa said it indicated its belief that the board undertake measures to effect and facilitate the imminent retirement of Harvey Berger as CEO and that any settlement of a potential proxy contest must include the CEO’s retirement. It added that no settlement has been reached. Sarissa believes the board "as currently constructed is not up to the task of providing the stewardship necessary to optimally navigate" the company. On February 19, Sarissa notified ARIAD that it intends to appear at the company's 2015 annual meeting of stockholders to nominate and seek to elect Richard Mulligan, Ph.D. and Anna Protopapas to the eight member staggered board of directors. Sarissa intends to seek to unseat Harvey Berger, ARIAD's Chairman and CEO, and Wayne Wilson, the lead independent director, with its two nominees. Sarissa added that it is "extremely concerned" with the conduct of certain members of the board, "particularly with respect to compensation, governance and financial matters." The hedge fund said it may ultimately initiate court proceedings to seek to remove one or more directors for cause based on potential breaches of their fiduciary duties. Sarissa Capital has a 6.9% stake in ARIAD.
February 19, 2015
08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.
07:39 EDTARIAARIAD expects to file IND application for AP32788 this year
ARIAD says "We expect to file an investigational new drug application for AP32788 this year and to begin a Phase 1/2 proof-of-concept trial in 2016. This will be our third IND filing of an internally discovered oncology development candidate in the past eight years." The company also says "We anticipate presenting updates from the ongoing Phase 1/2 clinical trial of brigatinib at the 2015 European Lung Cancer Conference and the American Society of Clinical Oncology meetings later this year. Additionally, we expect to present preliminary data from the brigatinib ALTA trial in the second half of 2015."
07:38 EDTARIAARIAD sees FY15 net product revenues from sales of Iclusig $130M-$140M
Net product revenues from sales of Iclusig are expected to be in the range of $130M-$140M. This guidance includes sales of Iclusig in the U.S., Europe, and other select countries where ARIAD has distributorships in place. R&D expenses are expected to be in the range of $185M-$195M, reflecting increased development activities for Iclusig, brigatinib, and AP32788, as well as ongoing discovery research efforts. Expenses related to Iclusig represent approximately 50% of total R&D expenses and include the three new planned trials to begin this year, as well as all ongoing trials. Expenses related to brigatinib represent approximately 35% of total R&D expenses and include the two ongoing trials and NDA-enabling pre-clinical studies.
07:37 EDTARIAARIAD reports Q4 EPS (3c), consensus (20c)
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use