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Tuesday, September 08, 2009

Osiris Therapeutics Shares Drop on Failed Drug Trial

By Matt Egan

FOXBusiness

Osiris Therapeutics (OSIR) saw its shares plunge almost 40% in pre-market trading Tuesday after the company said its drug for treating acute graft versus host disease failed a late-stage trial.

While the drug, Prochymal, showed “significant improvements” in response to hard-to-treat liver and gastrointestinal GvHD, neither trial met its primary goal.

GvHD is the most common complication of bone marrow transplantation and has no approved treatment.

“These data are still preliminary and further analysis is needed to gain a full appreciation of the results of these rigorous, double-blind, placebo-controlled trials,” CEO C. Randal Mills said in a statement. “We will meet with the FDA as soon as possible to discuss the most appropriate and efficient path forward for Prochymal in this life-threatening indication.”

Osiris said it plans to file an amendment with the FDA to broaden the entry criteria to include patients with severe GvHD of the liver.

Shares of Osiris slumped to $7.58 after closing at $12.19 on Friday. The company’s stock is down 36% year-to-date.

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