Human Genome Sciences Benlysta Drug Approval HGSI FDA Panel

News & Society

  • Author Brian Plain
  • Published December 22, 2010
  • Word count 438

Tomorrow is the big day! We finally see how Human Genome Sciences Blockbuster Hopes on Lupus Drug Benlysta Pans Out based on Human Genome Sciences Benlysta® Drug Approval for Lupus Patients (HGSI) by the FDA Panel Notes.

At our Trading School, we've been covering this stock for some times and we're very pleased with the drug benefits that Benlysta® brings to patients worldwide. We've seen positive results in near-term and long-term periods and we expect the FDA to clear Benlysta on December 9, 2010 and we expect positive FDA Panel notes tomorrow November 12, 2010.

We did a 1 hour radio show on topic which is archived here: Human Genome Sciences Benlysta® Drug Approval for Lupus Patients.

Human Genome Sciences (NASDAQ Symbol: HGSI) traded higher going into Thursday's Closing bell as Wall Street Trader bought up shares of HGSI over the past two trading days. Yesterday we saw HGSI move $.76 off the lows breaking the short term trading pattern on roughly 325% above average trading volume.

Today we saw HGSI share rocket higher on roughly 310% above average volumes as institutional buyers stepped in creating higher highs going into the news.

We saw "big block" purchases of stock on the opening bell today as someone purchased 100,000 shares at $24.25 a far superior entry compared to the larger "big block" purchase on the close of 231,600 shares at $26.48 4:09 PM EST.

StockMarketFunding.com and it's CEO Mario Marciano will continue to provide you with live updates on the equity and option prices for Human Genome Sciences (NASDAQ Symbol: HGSI).

Accord to Human Genome Sciences's website: "BENLYSTA® is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1996. We and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and commercialization agreement entered into in 2006."

In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues.

BENLYSTA® has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA® in the United States and Europe.

The FDA has granted BENLYSTA® a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA® could receive regulatory approval in the United States before the end of 2010.

For more information, watch the after hours video: Human Genome Sciences Benlysta Drug Approval for Lupus Patients (HGSI)

Senior Trader at the StockMarketFunding.com Pro Trading School. I joined StockMarketFunding.com as President of Trading after working 7 years at Fidelity Investment's Retirement Investments Group.

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