Human Genome Sciences, Inc. (HGSI) reported third quarter net loss of $49 million or 32 cents per share, in-line with the Zacks Consensus Estimate. The company reported a net loss of $74.2 million or 50 cents in the year ago quarter. The lower net loss for the quarter was primarily attributable to increased revenues from manufacturing and development services and lower operating expenses. Revenues for the quarter came in at $18.834 million which reflected an increase of 60.6%. Revenues were inclusive of $8.7 million from manufacturing and development services, $8.9 million recognized under the company’s agreement with Novartis (NVS) pertaining to hepatitis C drug Zalbin, and $1.0 million recognized under the agreement with GlaxoSmithKline plc (GSK) pertaining to the potential blockbuster lupus drug Benlysta. Research & development spend declined 36% to $34.8 million in the quarter. Selling general & administrative expenses declined 6.3% to ...

Earlier this week, Human Genome Sciences Inc. (HGSI) announced that its eagerly anticipated lupus drug Benlysta is expected to cost patients about $20,000 a year. The actual price might also be slightly more than the figure. Consequently, the drug could reach $1 billion in annual sales if taken by 50,000 patients, which represents a small fraction of those affected by the disease. In July 2009, Human Genome Sciences and GlaxoSmithKline PLC (GSK) announced that Benlysta met the primary endpoint in BLISS-52, the first of two pivotal phase III trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta 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 Benlysta was generally well tolerated, with adverse ...

Human Genome Sciences Inc. (HGSI) announced that it plans to raise approximately $310 million as net proceeds by selling 23.2 million common shares at $14 per share. This reflects an expansion of the initial public offering where the company had planned to sell 18 million shares in public.   The Rockville, Maryland-based company further stated that the underwriters would be given a month to buy up to an additional 3.48 million common shares to cover any over-allotments. The offering, expected to close on August 3, will lead to considerable dilution in the shareholder base.   Human Genome intends to use the proceeds for general corporate and acquisition or investment purposes. Additionally, this funding arrangement is also expected to provide cash for further development of the pipeline.   As a reminder, Human Genome has a robust and diversified pipeline which includes drugs to treat hepatitis C, lupus, anthrax, cancer, ...

This week, biopharmaceutical company Human Genome Sciences Inc. (HGSI) announced the commencement of an underwritten public offering of up to 18 million shares of its common stock. The Maryland-based company stated that the underwriters would be given a month’s period to buy up to an additional 2.7 million common shares. While the company should be able to raise funds sufficient to finance operations through this operation, the issuance of shares will lead to considerable dilution in the shareholder base. The company intends to use the proceeds for general corporate and acquisition or investment purposes. Additionally, this funding arrangement is also expected to provide cash for further development of the pipeline.

As a reminder, Human Genome has a robust and diversified pipeline, which includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The company has recently filed a Biologics License Application (BLA) for ABthrax for

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Most investors were not expecting good news. That is why shares of Human Genome Sciences (NASDAQ:HGSI) are soaring after the company released its latest Phase III results.

It has turned out to be my mantra over the past several weeks: big surprises lead to big gains.

Last Thursday, my colleague, Laura Cadden, and I got into a discussion of Human Genome Sciences (NASDAQ:HGSI) and its investment potential.

Knowing that I started in the industry by tracking and trading unique volume patterns, she came to me after noticing a strong up-tick in trading activity last week.

At a company that normally trades just shy of eight million shares each day, a sudden surge to the fifty-million level is going to get attention.

As the group’s in-house genomics expert, Laura knew the company was closing in on a pivotal announcement concerning its lupus drug Benlysta.

After sizing up the charts, reviewing the company’s massive debt

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Rockville, Maryland- based biopharmaceutical company Human Genome Sciences, Inc. (HGSI) announced today that that it will be selling 45,000 doses of raxibacumab or ABthrax to the U.S. Government for the Strategic National Stockpile. The delivery is to be made over a 36-month period, beginning the final quarter of 2009.The company expects to receive approximately $151 million from the completion of this order.

The company had delivered 20,000 doses of the drug, for emergency use in the treatment of inhalation anthrax, to the U.S. Strategic National Stockpile in the first quarter of this year and completed the delivery in the second quarter. It recognized $153.8 million in ABthrax revenue in the first quarter.

Human Genome is under contract to deliver doses of the drug to the U.S. Strategic National Stockpile, which stores huge quantities of medicine and medical supplies to be used in national emergencies like a flu outbreak, terrorist attacks or

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HGSI’s Benlysta meets its endpoints in Bliss-52 phase III trial for lupus Earlier today, Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK) announced that Benlysta met the primary endpoint in BLISS-52, the first of two pivotal phase III trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta 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 Benlysta was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. As a reminder, HGSI and GSK is co-developing Benlysta as a potential treatment for SLE. Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered ...

HGSI: NDA for Albuferon Expected to be Filed This FallWaiting for 2 Phase III Results for BenlystaNDA filing for Albuferon is expected in the fall for Hepatitis C      Albuferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences Inc. (HGSI) modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.HGSI has an exclusive worldwide agreement with Novartis (NVS) for the development and commercialization of Albuferon. The two companies are developing Albuferon as a potential treatment for chronic hepatitis C (HCV). Under this agreement, ...

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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