-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MAY8gjQMmlQKwN01fwnCphSKxpucoAFu5p1gGcDZ6EVnnN84PqROGi5sOR04B+40 1OtrMP4cBhQP3pc9IedFtA== 0000950129-06-003089.txt : 20060327 0000950129-06-003089.hdr.sgml : 20060327 20060324213001 ACCESSION NUMBER: 0000950129-06-003089 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20060324 ITEM INFORMATION: Other Events FILED AS OF DATE: 20060327 DATE AS OF CHANGE: 20060324 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ENCYSIVE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000887023 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133532643 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20117 FILM NUMBER: 06710576 BUSINESS ADDRESS: STREET 1: 4848 LOOP CENTRAL DRIVE STREET 2: SUITE 700 CITY: HOUSTON STATE: TX ZIP: 77081 BUSINESS PHONE: 7137968822 MAIL ADDRESS: STREET 1: 4848 LOOP CENTRAL DRIVE STREET 2: SUITE 700 CITY: HOUSTON STATE: TX ZIP: 77081 FORMER COMPANY: FORMER CONFORMED NAME: TEXAS BIOTECHNOLOGY CORP /DE/ DATE OF NAME CHANGE: 19930328 8-K 1 h34456e8vk.htm ENCYSIVE PHARMACEUTICALS INC. e8vk
 

 
 
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.
[SIGNATURE PAGE FOLLOWS]

 

 

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.
         
  ENCYSIVE PHARMACEUTICALS INC.
(Registrant)
 		  
Date: March 24, 2006  /s/ Paul S. Manierre    
  Paul S. Manierre   
  Vice President and General Counsel   
 

 

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