Osiris Therapeutics 8-K 2007
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 8, 2007
OSIRIS THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
Registrants telephone number, including area code: (410) 522 - 5005
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 7.01 Regulation FD Disclosure
On January 8, 2007, Osiris Therapeutics, Inc. announced that the U.S. Food and Drug Administration awarded Fast Tract status for its Crohns disease stem cell therapy, expediting the development of the stem cell treatment for Crohns Disease that does not respond to standard therapies. Additionally, the Company announced that it has received clearance to start a Phase III clinical trial using Prochymal to treat this resistant form of Crohns Disease. The Phase III program was developed in consultation with the FDA, and if successful, will be the last phase of testing before the company seeks full approval for Crohns Disease. The press release is attached hereto as an exhibit to this Current Report on Form 8-K and is being filed pursuant to this Item 7.01 as Exhibit 99.1 to this Current Report on Form 8-K.
The information included herein, including Exhibit 99.1 furnished herewith, shall not be deemed to be filed for purposes of Section 18 of the Securities Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such filing.
ITEM 9.01. Financial Statements and Exhibits
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.