UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 23, 2008
Athersys, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-33876 | 20-4864095 | ||
| (State or other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 3201 Carnegie Avenue, Cleveland, Ohio |
44115-2634 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (216) 431-9900
| (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 240.14a-12)
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 8.01. Other Information
On September 23, 2008, Athersys, Inc. issued a press release announcing that the U.S. Food and Drug Administration has requested additional information relating to Athersys’ Investigational New Drug Application for a Phase II clinical trial of ATHX-105, the Company’s lead product candidate for obesity, and has placed the study on partial hold. Additionally, the Company announced the completion of two Phase I studies in the United Kingdom, which are part of its ongoing efforts to assess the safety and tolerability of ATHX-105. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit No. | Exhibit Description | |
99.1 |
Press Release dated September 23, 2008 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: September 25, 2008
ATHERSYS, INC.
By: /s/ Laura K. Campbell
Name: Laura K. Campbell
Title: Vice President, Finance
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EXHIBIT INDEX
| Exhibit No. | Exhibit Description | |
99.1 |
Press Release dated September 23, 2008 |
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