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: September 28, 2005
(Date of earliest event reported)

 

INCYTE CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware

 

0-27488

 

94-3136539

(State or Other
Jurisdiction of
Incorporation)

 

(Commission File
Number)

 

(I.R.S. Employer
Identification Number)

 

 

 

 

 

Experimental Station, Route
141 & Henry Clay Road,
Building E336
Wilmington, DE

 

19880

(Address of principal executive
offices)

 

(Zip Code)

 

(302) 498-6700

(Registrant’s telephone number,
including area code)

 

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 EVENTS.

 

On September 28, 2005, Incyte Corporation (“Incyte”) publicly announced that it met with representatives from the Food and Drug Administration (“FDA”) on September 27, 2005, regarding the development of ReversetTM, Incyte’s nucleoside reverse transcriptase inhibitor (“NRTI”) that is being developed as a therapy for treatment-experienced HIV patients.

 

The purpose of the meeting was to discuss the results of a recently completed Phase II trial, which were presented in July 2005 at the International AIDS Society meeting, and Incyte’s plans to move Reverset into two Phase III pivotal trials. At the meeting, the FDA did not approve of Incyte’s moving into Phase III studies. The agency requested that Incyte conduct another Phase II trial to provide additional data to support the efficacy and safety demonstrated in the original Phase II study with the drug.

 

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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.

 

Dated:  September 28, 2005

 

 

INCYTE CORPORATION

 

 

 

 

 

By:

/s/ Patricia A. Schreck

 

 

Patricia A. Schreck

 

 

Executive Vice President and

 

 

General Counsel

 

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