New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
July 28, 2014
05:36 EDTAZN, QGENQIAGEN, AstraZeneca announce collaboration
QIAGEN (QGEN) announced a collaboration agreement with AstraZeneca (AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer, or NSCLC. The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.
News For QGEN;AZN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
August 3, 2015
05:39 EDTAZNIsis Pharmaceuticals and AstraZeneca collaborate to develop antisense drugs
Isis Pharmaceuticals (ISIS) and AstraZeneca (AZN) announced a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. The new collaboration builds on a broad existing relationship between the two companies and supports AstraZeneca's strategic approach in these therapeutic areas using novel RNA-targeted treatments. It also enables Isis Pharmaceuticals to extend use of its antisense technology to diseases of the kidney. AstraZeneca will pay an upfront fee of $65M to Isis Pharmaceuticals plus development and regulatory milestones for each program that AstraZeneca advances to clinical development. Isis Pharmaceuticals is also eligible to earn tiered double-digit royalties on annual net sales for each program. This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.
July 30, 2015
09:10 EDTAZNAstraZeneca CEO: Acquisition purchasing prices 'pretty hefty,' Reuters reports
Subscribe for More Information
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 29, 2015
16:12 EDTQGENQIAGEN sees Q3 adjusted EPS 29c-30c, consensus 29c
Subscribe for More Information
16:11 EDTQGENQIAGEN sees FY15 adjusted EPS $1.16-1.18, consensus $1.10
Sees FY15 adjusted net sales to rise approximately 4% CER in 2015, as growth of about 7-8% CER in the core portfolio exceeds the adverse impact of approximately 3-4 percentage points from lower U.S. HPV sales. FY15 revenue consensus $1.32B.
16:09 EDTQGENQIAGEN reports Q2 adjusted EPS 26c, consensus 25c
Subscribe for More Information
July 28, 2015
07:20 EDTAZNBrookings Institute to hold a public meeting
Subscribe for More Information
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
Subscribe for More Information
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.

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