Human Genome Sciences (NASDAQ:HGSI) shares trading soared 10.50% in After
Hours after an endorsement from a government advisory panel. The advisory panel
backs Human Genome lupus drug Benlysta. Benlysta could become the first medicine
in a half-century to win approval for fighting the debilitating and potentially
fatal autoimmune disease. It has been anticipated that this news will transform
the company from Unprofitable segment to the Industry Star. Analysts'
forecasted the annual global sales of $2.2 billion by 2014. The FDA Arthritis
Advisory Committee voted 13-2 in favor of Benlysta approval for the treatment of
systemic lupus erythematosus. While discussions centered primarily on Benlystas
mild efficacy benefit, lower response rate is found in patients of African
descent and trial design,the panel voted 10-5 that the data demonstrated
substantial evidence of efficacy. In terms of the safety profile, the vote was
14-1 in favor of approval given the small patient numbers . The proposed drug
includes long-term safety analyses from ongoing trials (1,293 currently on drug)
and several post-marketing studies. Lupus is a disease that causes the immune
system to attack the bodys own tissue and organs and can lead to arthritis,
kidney damage, chest pain, fatigue, skin rash and other problems. Organ damage
can be fatal, and current treatments have severe side effects. However FDA
reviewers said that this drug might raise the risk of death, infection, or
psychiatric problems including suicide. Human Genome Sciences (HGS) is a
commercially focused biopharmaceutical company. The Company has three products
in late-stage clinical development: BENLYSTA for systemic lupus erythematosus
(SLE), ZALBIN for chronic hepatitis C, and raxibacumab for inhalation anthrax.
Disclaimer: The assembled information distributed by epicstockpicks.com is for
information purposes only, and is neither a solicitation to buy nor an offer to
sell securities. Epicstockpicks.com does expect that investors will buy and sell
securities based on information assembled and presented herein.
EpicStockPicks.com will not be responsible in any way for or accept any
liability for any losses arising from an investor's reliance on or use of
information obtained from our website or emails. PLEASE always do your own due
diligence, and consult your financial advisor.
No comments:
Post a Comment