Key Developments: Osiris Therapeutics Inc (OSIR.OQ)

OSIR.OQ on NASDAQ Stock Exchange Global Market

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17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Osiris Therapeutics Inc updates on acquisition of Osiris' culture-expanded mesenchymal stem cell business
Wednesday, 9 Apr 2014 08:00am EDT 

Osiris Therapeutics Inc:On Oct. 2013 signed agreement with subsidiary of Mesoblast Ltd.For acquisition of Osiris' culture-expanded mesenchymal stem cell (ceMSC) business, including Prochymal.Transaction worth upto $100 mln in initial consideration and milestone payments as well as future royalties.On April 8, receipt of $15 mln cash payment for Prochymal.  Full Article

Osiris Therapeutics Inc confirms Lode Debrabandere as president and chief executive officer
Tuesday, 14 Jan 2014 08:00am EST 

Osiris Therapeutics Inc:Says its Board of Directors, at a Special Meeting held on Jan. 13, 2014, confirmed the nomination of Lode Debrabandere, as President and Chief Executive Officer of the company.  Full Article

Osiris Therapeutics Inc Announces Leadership Transition
Monday, 2 Dec 2013 04:30pm EST 

Osiris Therapeutics Inc:Says C. Randal Mills, PhD. will be stepping down as President and Chief Executive Officer of the company for personal reasons.Says Osiris` Chief Operating Officer, Lode Debrabandere, Ph.D., will assume the role of President and Chief Executive Officer pending Board confirmation.  Full Article

Osiris Therapeutics Inc Announces Agreement For Sale Of Culture-Expanded MSCs Including Prochymal Worth Up To $100 Million Plus Royalties To Mesoblast Ltd's Subsidiary
Thursday, 10 Oct 2013 07:12pm EDT 

Osiris Therapeutics Inc announced that it has entered into an agreement with a wholly owned subsidiary of Mesoblast Ltd for the sale of Osiris' culture-expanded mesenchymal stem cell (ceMSC) business, including Prochymal, in a transaction worth up to $100 million in initial consideration and milestone payments. Additionally, Osiris will receive royalty payments on sales of Prochymal and other products utilizing the acquired ceMSC technology. Summary of the Transaction: Mesoblast has acquired the assets related to Osiris` ceMSC business; Osiris will receive $50 million in consideration for closing and delivery of its ceMSC assets; Osiris is eligible to receive up to an additional $50 million in payments upon Mesoblast achieving certain clinical and regulatory milestones; Mesoblast will assume all future development costs for the ceMSC business; Osiris will receive single to low double-digit royalties on product sales derived from the ceMSC technology; Osiris and Mesoblast have entered into a separate services agreement for continued product advancement and to ensure a seamless transition; Osiris has retained a license to all transferred intellectual property necessary to run its other businesses; and For Osiris, the transaction results in pro forma cash, investments and receivables of approximately $82 million. Osiris expects to record the closing and asset transfer consideration of $51 million in the fourth quarter of fiscal 2013.  Full Article

Osiris Therapeutics Inc Announces Conclusion Of Collaboration With Sanofi SA's Genzyme
Friday, 28 Sep 2012 12:00am EDT 

Osiris Therapeutics Inc announced the conclusion of its collaboration with Genzyme, a Sanofi SA company. As the Collaboration Agreement is now ended, all rights to Prochymal and Chondrogen worldwide revert back to Osiris. Osiris is now free to commercialize or enter into commercialization agreements for Prochymal and Chondrogen with other parties without limitation. Both parties have agreed to an orderly conclusion of the collaboration, with no further financial responsibilities for either party, and an amicable end to their relationship.  Full Article

Osiris Therapeutics, Inc. Announces Interim One Year Results From Clinical Trial Evaluating Prochymal
Monday, 2 Jul 2012 08:15am EDT 

Osiris Therapeutics, Inc. announced interim one-year results from its groundbreaking clinical trial evaluating Prochymal(remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the study of allogeneic or off-the-shelf stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack. Cardiac MRI assessments were conducted for six months following infarct to evaluate cardiac remodeling. Patients receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p<0.05). Patients treated with Prochymal also experienced significantly less stress-induced ventricular arrhythmia (p<0.05). Cardiac hypertrophy and ventricular arrhythmia are indicators of pathological remodeling following heart injury and provide insight into the mechanism by which mesenchymal stem cells attenuate heart injury following a myocardial infarction. The mechanistic data is complemented by clinical data showing treatment with Prochymal resulted in a statistically reduction in heart failure. The trial also demonstrated that treatment with Prochymal was safe. There were no infusional toxicities observed in patients receiving Prochymal. Serious adverse events occurred with equal frequency in both treatment groups (31.8%).  Full Article

Osiris Therapeutics, Inc. Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent By New Zealand
Thursday, 14 Jun 2012 08:00am EDT 

Osiris Therapeutics, Inc. announced that it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. Osiris submitted a New Medicine Application (NMA) to Medsafe (New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981. Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64% of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival. It is expected that Prochymal will be commercially available in New Zealand later this year.  Full Article

Osiris Therapeutics, Inc. Shares Rose On Nod For Wound Treatment Reimbursement-Reuters
Wednesday, 30 May 2012 01:46pm EDT 

Reuters reported that shares of Osiris Therapeutics, Inc. rose 15% on May 30, 2012, after U.S. health regulators said the stem cell technology company's wound treatment was eligible for reimbursement when used in hospitals in out-patient settings or in ambulances. The Center for Medicare & Medicaid Services also cleared the pathway for a permanent reimbursement code for Grafix, Osiris's wound-care matrix containing stem cells, on May 29, 2012. A permanent code makes reimbursement for the treatment faster and easier, thus increasing the chances of a physician prescribing it. Osiris said if the permanent reimbursement code for Grafix was approved, it could become effective from January next year.  Full Article

Osiris Therapeutics, Inc. Receives Marketing Clearance From Health Canada For Prochymal
Thursday, 17 May 2012 04:36pm EDT 

Osiris Therapeutics, Inc. announced that it has received market authorization from Health Canada to market its stem cell therapy Prochymal(remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.  Full Article

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