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 5, 2007 |
Encysive Pharmaceuticals Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 0-20117 | 13-3532643 |
| _____________________ (State or other jurisdiction | _____________ (Commission | ______________ (I.R.S. Employer |
| of incorporation) | File Number) | 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:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On September 5, 2007, Encysive Pharmaceuticals Inc. (the "Company") issued a press release announcing that it had received a written response from the U.S. Food and Drug Administration (FDA) regarding Encysive's request for formal dispute resolution on its New Drug Application for Thelin(tm) (sitaxsentan sodium) for the treatment of pulmonary arterial hypertension (PAH). A copy of the press release is filed as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press release issued September 5, 2007.
[SIGNATURE PAGE FOLLOWS]
This current report on Form 8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are: the unpredictability of the FDA formal dispute resolution process; unexpected delays in regulatory review and approval of ThelinTM by the FDA in the U.S. and our other products under development; possible delays in the timelines for initiating clinical trials and obtaining results of clinical trials with respect to our products under development; the high cost and uncertainty of the clinical trials and other development activities involving our products and compounds; our estimate of the sufficiency of our existing capit al resources; our ability to raise additional capital to fund cash requirements for future clinical trials; our ability to successfully conduct a ThelinTM pivotal trial; the availability of sufficient funds to commercialize ThelinTM in the U.S. should it be approved by the FDA, as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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. | ||||
| September 7, 2007 | By: | /s/ Paul S. Manierre | ||
| Name: Paul S. Manierre | ||||
| Title: Vice President, General Counsel and Secretary | ||||
Exhibit Index
| Exhibit No. | Description | |
99.1 | Press release issued September 5, 2007 |
