Scimitar Equity Blog

OSIR reported net Income of $4.5M or $0.14 per share. Read more…

Net income was $1.7 M and $0.05 per diluted common share. Read more…

The Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review OSIR’s New Drug Submission (NDS) of Prochymal (remestemcel-L),

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Q1/10 earnings fell 84 % but, posted a profit of $2.4 M, or $0.07 per diluted common shares, versus a profit of $14.8 M, or a $0.24 loss per share, in Q1/09.  Q1/10 revenue fell 10 % to $11.3 M coming from the Genzyme Corp agreement licensing fee and a $1 M milestone payment from a venture with JCR Pharmaceuticals. Read more…

OSIR announced that it is resuming enrollment in its clinical trial evaluating Prochymal for patients with treatment-resistant Crohn’s disease. The findings of an interim analysis showed that for the primary endpoint of disease remission, Prochymal is approaching statistical significance in the intent to treat (ITT) population, and has reached significance in the per protocol population. Additionally, the analysis showed that Prochymal continued to demonstrate a benign safety profile with no significant differences in any of the pre-defined safety outcomes compared to placebo. Read more…

OSIR has been granted Orphan Drug designation from the US FDA for Prochymal as a treatment for type 1 diabetes mellitus. The FDA instituted the Orphan Drug Act to promote the development of treatments for underserved patient populations. To be eligible for Orphan Drug designation, the treatment must target a disease that affects fewer than 200,000 new patients per year in the US. Read more…

Osiris Therapeutics is a stem cell therapeutic company focused on developing products in the inflammatory, orthopedic and cardiovascular areas.  OSIR’s  Q4/09 results reported achievement and data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage GvHD with significant improvement in response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD – the two most deadly and difficult-to-treat forms of the disease.  Graft-versus-host disease (GvHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack.

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