-----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, UgRAVCqa3aRpNI93u1ozxUHnFdNLzoUgEVZjh1KZ5YGlt533IC/TE1A/q6ptP2iq 1yCIdLi45DdWP2RbGFfoOA== 0001157523-09-002213.txt : 20090319 0001157523-09-002213.hdr.sgml : 20090319 20090319160341 ACCESSION NUMBER: 0001157523-09-002213 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20090319 ITEM INFORMATION: Other Events FILED AS OF DATE: 20090319 DATE AS OF CHANGE: 20090319 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DYAX CORP CENTRAL INDEX KEY: 0000907562 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 043053198 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24537 FILM NUMBER: 09693521 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 MAIL ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 STREET 2: 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: BIOTAGE INC DATE OF NAME CHANGE: 19951117 8-K 1 a5921890.htm DYAX CORP. 8-K

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 19, 2009

DYAX CORP.
(Exact Name of Registrant as Specified in Charter)

Delaware

000-24537

04-3053198

(State or Other Jurisdiction of

Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

300 Technology Square
Cambridge, MA 02139

(Address of Principal Executive Offices) (Zip Code)

(617) 225-2500
(Registrant’s telephone number, including area code)

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.

The U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research (“CDER”), which is currently conducting a priority review of Dyax’s DX-88 in acute attacks of hereditary angioedema (“HAE”), notified Dyax today that they miscalculated the Company’s Prescription Drug User Fee Act (“PDUFA”) target action date. Initially, Dyax was informed that its action date would be six months from the submission of its biologic license application (“BLA”), or March 23, 2009, as is the practice for a new drug application (“NDA”) reviewed by CDER. Because DX-88 is a biologic agent, however, the action date should have been calculated based on the number of days in a month from the submission of the BLA, or March 25, 2009, as is the practice for a BLA reviewed by the FDA’s Center for Biologics Evaluation and Research (“CBER”). Therefore, the corrected PDUFA date is March 25, 2009.

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.

			DYAX CORP.


Dated:	March 19, 2009	By:	/s/ Ivana Magovcevic-Liebisch
			Ivana Magovcevic-Liebisch
			Executive Vice President of Administration
			and General Counsel

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