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): January 30, 2001
----------------
Curis, Inc.
--------------------------------------------------
(Exact Name of Registrant as Specified in Charter)
Delaware
--------------------------------------------------
(State or Other Jurisdiction of Incorporation)
000-30347 04-3505116
- ------------------------ ------------------------------------
(Commission File Number) (I.R.S. Employer Identification No.)
61 Moulton Street
Cambridge, Massachusetts 02138
- ---------------------------------------- -------------
(Address of Principal Executive Offices) (Zip Code)
(617) 503-6500
--------------------------------------------------
(Registrant's Telephone Number, Including Area Code)
Not Applicable
--------------------------------------------------
(Former Name and Former Address, if Changed Since Last Report)
ITEM 5. OTHER EVENTS.
On January 30, 2001, Curis, Inc. issued a press release in which Curis
reported an announcement by Stryker Corporation reporting that it received a
Not-Approvable Letter from the U.S. Food and Drug Administration regarding its
Pre-Market Approval for OP-1 Implant(TM) for use in treating nonunion fractures
of the tibia.
A copy of the press release is filed as Exhibit 99.1 to this Report and is
incorporated herein by reference. The information contained in the website
cited in the press release is not a part of this Report.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND
EXHIBITS.
(a) Financial Statements of Business Acquired.
-----------------------------------------
Not applicable.
(b) Pro Forma Financial Information.
-------------------------------
Not applicable.
(c) Exhibits.
--------
Exhibit Description
------- -----------
99.1 Press release of Curis, Inc. issued January 30, 2001
announcing that the OP-1 PMA received a Not-Approvable
Letter from the FDA
2
SIGNATURE
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: January 30, 2001 CURIS, INC.
---------------------------------
(Registrant)
By: /s/ GEORGE A. ELDRIDGE
----------------------
George A. Eldridge
Vice President, Chief Financial
Officer, Secretary and Treasurer
3
EXHIBIT INDEX
Exhibit Description
------- -----------
99.1 Press release of Curis, Inc. issued January
30, 2001 announcing that the OP-1 PMA
received a Not-Approvable Letter from the FDA.
4