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News Breaks
June 12, 2014
13:29 EDTAZN, NKTRNektar Naloxegol can still be approved around end of year, says Piper Jaffray
After most members of an FDA panel voted against requiring a cardiovascular outcomes trial for Nektar's (NKTR) and AstraZeneca's (AZN) naloxegol and other similar drugs drugs, Piper Jaffray thinks the vote seems to be positive for Nektar. However, the firm thinks the drug's precise path to market remains uncertain, given what it sees as "FDA dysfunction." Piper continues to believe that the most likely outcome is that the drug will be approved around the end of 2014 and be launched in the first quarter of 2015. It reiterates an Overweight rating on Nektar.
News For NKTR;AZN From The Last 14 Days
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July 30, 2015
07:25 EDTAZNCharles River, AstraZeneca renew strategic partnership agreement
Charles River Laboratories International (CRL) announced that it has extended its initial three-year partnership with AstraZeneca (AZN) for an additional five-year period. Under the agreement, which extends into 2020, Charles River retains its position as AstraZeneca’s preferred strategic partner for outsourced regulated safety assessment and development DMPK.
05:57 EDTAZNRoche submits filing to FDA for companion diagnostic for NSCLC drug therapy
Roche announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval, or PMA, to the FDA, as a companion diagnostic test for AZD9291, an AstraZeneca (AZN) investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation. Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.
July 28, 2015
07:20 EDTAZNBrookings Institute to hold a public meeting
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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.

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