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News Breaks
June 12, 2014
07:44 EDTNKTR, PGNX, AZN, SLXPFDA Anesthetic & Analgesic Drug Products Advisory Committee holds a meeting
The Committee reviews opioid antagonists being developed for opioid induced constipation including Progenics' and Salix Pharmaceuticals' Subcutaneous RELISTOR and Nektar Therapeutics and AstraZeneca's Naloxegol in a meeting being held at FDA Silver Spring, Maryland offices on June 12 at 8 am. Webcast Link
News For AZN;NKTR;SLXP;PGNX From The Last 14 Days
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July 27, 2015
05:25 EDTAZNGenzyme acquires Caprelsa from AstraZeneca for $300M
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
July 22, 2015
13:58 EDTAZNPiper cuts Array target by only 50c after failed trial
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
09:07 EDTAZNOn The Fly: Pre-market Movers
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
July 16, 2015
15:42 EDTNKTRNektar partner Baxalta releases complete data from Phase II/III BAX 855 study
Nektar Therapeutics (NKTR) reported that partner Baxalta announced the publication of the complete data from the Phase II/III pivotal study and Phase I trial of BAX 855 in Blood, the journal of the American Society of Hematology. BAX 855 is Baxalta's investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, a leading treatment for hemophilia A with more than 11 years of real-world patient experience. Through a collaboration with Nektar, BAX 855 leverages proprietary pegylation technology designed to prolong the amount of factor VIII available for use in the body. As previously disclosed, BAX 855 met the study's primary endpoint for the prevention of bleeding episodes and the treatment with prophylaxis compared to on-demand treatment. Patients in the twice-weekly prophylaxis arm of the trial experienced a 95% reduction in median annualized bleed rate as compared with those in the on-demand arm. BAX 855 was also effective in treating all bleeding episodes, 95.9% of which were controlled with one or two infusions at a median dose of 29.0 IU/kg per infusion.
July 15, 2015
17:00 EDTAZNInnerWorkings to provide AstraZeneca exclusive marketing execution
InnerWorkings (INWK), the leading marketing execution firm, has become the exclusive North American marketing execution partner of AstraZeneca (AZN). Under the seven-year agreement, InnerWorkings will manage AstraZeneca’s marketing print operations across North America, which will improve AstraZeneca’s transparency and reporting as well as strengthen its brand impact. Strategically placed across the U.S., InnerWorkings’ three onsite teams based in Delaware, Maryland, and Pennsylvania will help AstraZeneca sharpen its financial visibility, unify its brands, and enhance its marketing effectiveness. By tapping InnerWorkings’ $1B-dollar buying power, AstraZeneca will gain vital insights, promote sustainability, and refine its marketing spend.
08:49 EDTPGNXProgenics management to meet with Brean Capital
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06:39 EDTPGNXCytoDyn appoints Paul Maddon as Senior Science Advisor
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