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): March 24, 2006
Encysive Pharmaceuticals Inc.
(Exact name of registrant as specified in its charter)
| | | | | |
| Delaware | | 0-20117 | | 13-3532643 |
| |
(State or other jurisdiction
of incorporation) | | (Commission
File Number) | | (IRS Employer
Identification No.) |
| | | | | |
4848 Loop Central Drive, Suite 700, Houston, Texas
| | 77081 |
| |
(Address of principal executive offices)
| | (Zip Code) |
Registrant’s telephone number, including area code:713-796-8822
Not Applicable
(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 (see General Instruction A.2. below):
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 Events.
Encysive Pharmaceuticals Inc. (the “Company”) announced today that the Company has received an approvable letter from the U.S. Food and Drug Administration (“FDA”) for Thelin™ (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (“PAH”). The action letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work. The Company will work in close collaboration with the FDA to address their concerns and questions. Until these discussions are completed, the Company is unable to estimate the ultimate timing of final approval or the scope of any additional submissions to the FDA.
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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.
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| | ENCYSIVE PHARMACEUTICALS INC.
(Registrant)
| |
| Date: March 24, 2006 | /s/ Paul S. Manierre | |
| | Paul S. Manierre | |
| | Vice President and General Counsel | |
| |
