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Stem Cell Index Surges in Past Week
OSIR
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-51.31%
in
201 days
<> The stem cell trade was back in a big way over the past week, with several stocks in the <font> ETF Innovators Stem Cell Index </font> registering impressive gains, compared to market and biotech ETF benchmarks such as the S&P 500 SPDR (NYSE:SPY) +6%, iShares Nasdaq Biotech (NASDAQ:IBB) +2%, SPDR S&P Biotech (NYSE:XBI +4%). Hot stocks over the past week among the 40 component companies in the stem cell index include NeoStem (AMEX:NBS) +52.2%, Cytori Therapeutics (NASDAQ:CYTX) +37%, and Geron (NASDAQ:GERN) +22%. Two other widely followed stocks from the index registered smaller gains,...
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FDA, Clinical Trial Calendar Updates: Genzyme, Isis, Osiris, Roche, Watson
OSIR
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+7.66%
in
18 days
(closed on 05/10/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete r...
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Osiris Completes Phase 3 Enrollment, Initiates FDA Filing
OSIR
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-6.27%
in
5 days
(closed on 04/22/09)
Posted by: Mike Havrilla in Untagged on Apr 17, 2009 <!-- Post Teaser Text --> <> On 4/17/09, OSIR announced that it has successfully completed patient enrollment in its pivotal, Phase III trial evaluating Prochymal as a first-line treatment for acute graft vs. host disease (GvHD), a life-threatening complication of bone-marrow transplantation. Prochymal Phase 3 Results for graft-vs-host disease (GvHD) Expected 2H09 for both trials. <> The double-blind, placebo-controlled trial enrolled 190 patients from 52 leading transplant centers ac...
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Stem Cell Index: YTD Analysis, Banking on NeoStem
OSIR
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+6.87%
in
6 days
(closed on 04/17/09)
<> <> <> <!-- <td valign="top" width="1%"> <img src="/images/quotes.gif" /> </td> --> <> <> Related Tickers: NBS, IART, OSIR, STEM, GE, XLV, IBB, XBI, PBE, SPY Disclosure: No Positions <> The ETF Innovators Global Stem Cell and Regenerative Medicine Index tracks the performance of 40 stem cell and regenerative medicine companies on a globa...
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FDA and Clinical Trial Calendar Updates
OSIR
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-11.57%
in
15 days
(closed on 04/11/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 106 entries through 3/27/09. The FDA Calendar includes the following information: company name...
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From the Blogosphere
Osiris Posts Loss – Analyst Blog
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Osiris Therapeutics (OSIR) reported a net loss of 21 cents per share in the third quarter of 2009, well above the Zacks Consensus Estimate of a net income of 6 cents. However, net loss in the year ago period was higher at 63 cents, mainly due to lower revenues.
Revenues in the reported quarter increased to $10.6 million compared to $0.995 million for the same period of the prior year. Osiris generates revenues from collaborative agreements, research licenses, and government contracts.
Revenues in the reported quarter included the recognition of $10 million in revenue under the company’s a<><>< />< />< />< />< />< />< />< />< />< />< />< />< /><>< /><>< /><>< /><><>< /><>< /><>< />< />...
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Optimistic on Osiris Therapeutics
By: Jason Napodano, CFA Osiris Therapeutics, Inc. (OSIR) reported financial results for the first quarter 2009 on May 7, 2009. Total revenues in the quarter were $12.7 million, up from $0.4 million for the same period for 2008, and slightly above our forecasts of $11.8 million.
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Osiris Hits a Speedbump in Crohn's Program
On March 27, 2009, Osiris Therapeutics (OSIR) announced it was stopping its phase III clinical trial program testing Prochymal for the treatment of acute Crohn’s disease (CD) due to a design flaw in the trial that was allowing for significantly higher-than-expected placebo response rates.
The decision was made after the trial’s final scheduled interim analysis showed that 1 of the 2 Prochymal dose arms had crossed a futility boundary (would not achieve statistical significance).
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Morning Movers 3/27: SMOD, GM, FREE, SNX, FINL Higher; OSIR, MGM, DYAX, YGE, KHD Lower
Osiris Therapeutics, Inc. (NASDAQ: OSIR) 25.5% LOWER; announced today that it has elected to end enrollment at 210 patients in its Phase III trial evaluating Prochymal for Crohn's disease. Click here for the full report.Smart Modular Technologies (Nasdaq: SMOD) 19.9% HIGHER; reports Q2 EPS of $0.06, versus the analyst estimate of ($0.01). Revenue for the quarter was $109.1 million, versus the consensus of $124.16 million. Sees Q3 revs of $95-$105 million, versus the consensus of $126 million, with EPS of $0.00-$0.01, versus the Street estimate of a loss of $0.01. Announces $10 million buyba...
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Stem Cell Index Soars on Lift of Funding Ban
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