23:04 , Oct 26, 2018 |  BC Extra  |  Politics & Policy

FDA grants first qualification of a clinical safety biomarker

FDA qualified a group of kidney injury biomarkers from the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC), marking the first...
07:00 , Oct 24, 2016 |  BC Week In Review  |  Clinical News

Custirsen sodium: Phase III final data

Final data from the open-label, international Phase III ENSPIRIT trial in 664 patients with advanced or metastatic stage IV NSCLC who progressed after first-line chemotherapy showed that once-weekly 640 mg IV custirsen plus docetaxel missed...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Custirsen sodium: Phase III data

Top-line data from the open-label, international Phase III AFFINITY trial in 634 patients with metastatic CRPC who progressed after first-line treatment with docetaxel showed that once-weekly 640 mg IV custirsen following 3 loading doses plus...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

Restructuring watch

Restructuring watch Date Company Staff cuts Cash Yrs cash pre-cut Cash date 12-mo op loss ended 12/31 1/7/16 Sequenom Inc. (NASDAQ:SQNM) 20% to 390 $76.2 9.65 12/31/15 $7.9 Sequenom restructured to focus on women's health...
08:00 , Feb 15, 2016 |  BC Week In Review  |  Company News

OncoGenex cancer news

OncoGenex will reduce headcount by 11 (27%) to 30 to focus on reaching several near-term clinical milestones for custirsen and apatorsen. The company expects cost savings from the headcount reduction, plus the elimination of expenditures...
08:00 , Dec 7, 2015 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 12/4 cls Cepheid Inc. (NASDAQ:CPHD) Wells Fargo Tim Evans Downgrade Market perform (from outperform) -10% $33.43 Evans also lowered his...
07:00 , Jul 20, 2015 |  BC Week In Review  |  Clinical News

Custirsen sodium: Phase III amended

OncoGenex said FDA agreed with the biotech’s amendment for the open-label, international Phase III AFFINITY trial comparing 640 mg IV custirsen weekly following 3 loading doses plus Jevtana cabazitaxel and prednisone vs. Jevtana plus prednisone...
07:00 , Jul 20, 2015 |  BC Week In Review  |  Clinical News

Custirsen sodium: Phase III ongoing

OncoGenex said an IDMC recommended continuation of the open-label, international Phase III ENSPIRIT trial comparing weekly 640 mg IV custirsen plus IV Taxotere docetaxel given on day 1 of a 21-day cycle vs. Taxotere alone...
07:00 , May 25, 2015 |  BC Week In Review  |  Company News

OncoGenex, Teva deal

The partners completed the termination of a 2009 deal granting Teva exclusive, worldwide rights to develop and commercialize custirsen sodium ( OGX-011 ), a second-generation antisense inhibitor of serum clusterin mRNA . Teva paid OncoGenex...
08:00 , Jan 5, 2015 |  BC Week In Review  |  Company News

OncoGenex, Teva deal

The partners will terminate a 2009 deal granting Teva exclusive, worldwide rights to develop and commercialize custirsen sodium ( OGX-011 ). OncoGenex said Teva will pay a $27 million termination fee payable upon the completion...