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Monday, 12/09/2013 5:02:51 AM

Monday, December 09, 2013 5:02:51 AM

Post# of 366147
GILD has two big news stories.

First they were approved by the FDA on Friday after hours. Then at 0312hrs EST thay send out this news brief.

3:12 am Gilead Sciences announces pivotal Phase 2 data for Idelalisib in refractory indolent non-hodgkin's lymphoma (GILD) : Co announces results of a Phase 2 study evaluating idelalisib, an investigational oral inhibitor of PI3K delta, for the treatment of patients with indolent non-Hodgkin's lymphoma that is refractory to rituximab and to alkylating-agent-containing chemotherapy. In this study, single-agent treatment with idelalisib achieved an overall response rate of 57% with a median duration of response of 12.5 months.

Of the 71 patients who responded to therapy, seven (6%) achieved a complete response, 63 (50%) had a partial response and one (one%) had a minor response. Among patients who responded, the median duration of response was 12.5 months and the median time to response was 1.9 months. Median progression-free survival for all patients was 11.0 months and median overall survival was 20.3 months. 90% of patients experienced shrinkage in lymph node size.

The most common Grade =3 adverse event was diarrhea, which was reported in 16 patients (13%). Grade =3 transaminase elevations (a measure of liver function) were reported in 16 patients (13%). Of the 16 patients who had Grade =3 transaminase elevations, 14 were retreated with idelalisib and of those, 10 (71%) had no recurrence. Grade =3 neutropenia occurred in 34 patients (27%). Twenty-five patients (20%) discontinued therapy because of adverse events.


http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#gild

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