La Jolla Pharmaceutical Shoots Up on Drug Application

Shares of La Jolla Pharmaceutical ( LJPC) were skyrocketing after the company said it will submit an application to the Food and Drug Administration for Riquent, its lupus drug.

Recently, the company's shares were up 46% to $2.99.

"Two of the largest well-controlled studies ever conducted in lupus patients have shown that Riquent was able to consistently reduce antibodies to double-stranded DNA and that patients with sustained reductions in antibodies to double-stranded DNA were less likely to have a renal flare," said Steve Engle, chief executive of the company. "Furthermore, treatment with Riquent was well tolerated."

The new drug application is expected to be completed by the end of the year, the company said, and further discussions with the FDA will be needed to clarify whether any additional studies will be necessary. La Jolla also plans to meet with European regulatory authorities to discuss potential next steps for Riquent in Europe. Lupus is a chronic, life-threatening autoimmune disease.

Additionally, San Diego-based La Jolla said results from its phase 3 trial did not reach statistical significance for its primary endpoint. The trial's results, however, demonstrated that lupus patients treated with Riquent had significantly lower levels of antibodies to double-stranded DNA (dsDNA) than patients treated with placebo.

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