September 4, 2009 - Shares of Human Genome Sciences, Inc. (HGSI) could get a lift today on the following news:
Human Genome Sciences, Inc. (NASDAQ:HGSI) today announced publication by the journal Arthritis Care & Research of an article describing the development and use of a novel evidence-based systemic lupus erythematosus (SLE) Responder Index selected as the primary endpoint of two pivotal Phase 3 clinical trials of BENLYSTA™ (belimumab) in serologically active patients with SLE. This primary endpoint was accepted by the FDA under a Special Protocol Assessment agreement for the Phase 3 trials.
In July 2009, HGS and GSK announced that belimumab met this primary endpoint in BLISS-52, the first of the two Phase 3 trials. Results from BLISS-76, the second Phase 3 trial, are expected in November 2009. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
Full Article - Click Here
Looking at the charts, HGSI stock needs to get back above the 10 day moving average at $18.60. If HGSI does close back above the 10 day, $20 is the next resistance level. HGSI has been falling ever since the Immunomedics Inc. (IMMU) news was released.
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Showing posts with label benlysta. Show all posts
Showing posts with label benlysta. Show all posts
Friday, September 4, 2009
Monday, July 20, 2009
Human Genome HGSI Stock Up on Lupus Drug - July 20 - 2009
July 20, 2009 - Shares of Human Genome Sciences Inc. (HGSI) are exploding higher this morning after positive data on their Lupus Drug is getting rave reviews! HGSI stock is up 209% to $10.25. Discuss HGSI
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HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE POSITIVE PHASE 3 STUDY RESULTS FOR BENLYSTA™
BENLYSTA (belimumab) met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo in BLISS-52 -
- First drug for lupus to reach this advanced stage of clinical development and achieve positive results, in the largest randomized placebo-controlled clinical trial ever completed in SLE patients
ROCKVILLE, Maryland, and LONDON, UK – July 20, 2009 – Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA™ (belimumab, formerly LymphoStat-B®) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
“The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010.” Full Article Here
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HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE POSITIVE PHASE 3 STUDY RESULTS FOR BENLYSTA™
BENLYSTA (belimumab) met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo in BLISS-52 -
- First drug for lupus to reach this advanced stage of clinical development and achieve positive results, in the largest randomized placebo-controlled clinical trial ever completed in SLE patients
ROCKVILLE, Maryland, and LONDON, UK – July 20, 2009 – Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA™ (belimumab, formerly LymphoStat-B®) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
“The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010.” Full Article Here
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