-----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, HNv2hRWtZUoc+47SJckgZjMpKpIvxPdq4yGQgQsAhz0qIvCNmSWDrNcjNCi6UzVW 6oN0fASEk/ez6WnzOpSMBA== 0001193125-06-073888.txt : 20060405 0001193125-06-073888.hdr.sgml : 20060405 20060405165416 ACCESSION NUMBER: 0001193125-06-073888 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060403 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060405 DATE AS OF CHANGE: 20060405 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CORTEX PHARMACEUTICALS INC/DE/ CENTRAL INDEX KEY: 0000849636 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330303583 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-16467 FILM NUMBER: 06742669 BUSINESS ADDRESS: STREET 1: 15241 BARRANCA PKWY CITY: IRVINE STATE: CA ZIP: 92718 BUSINESS PHONE: 7147273157 MAIL ADDRESS: STREET 1: 15241 BARRANCA PARKWAY CITY: IRVINE STATE: CA ZIP: 92718 8-K 1 d8k.htm FORM 8-K Form 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)

April 3, 2006

CORTEX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   1-16467   33-0303583

(State or other jurisdiction of

incorporation)

  (Commission File Number)   (I.R.S Employer Identification No.)

 

15241 Barranca Parkway

Irvine, California

  92618
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (949) 727-3157

N/A

(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 April 3, 2006, Cortex Pharmaceuticals, Inc., a Delaware corporation (the “Company”), issued a press release announcing that, pending further preclinical review, the United States Food and Drug Administration has placed a clinical hold on the Company’s clinical trials of AMPAKINE® CX717.

A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits.

 

Exhibit
Number
  

Description

99.1    Press Release of Cortex Pharmaceuticals, Inc. dated April 3, 2006.


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.

 

    CORTEX PHARMACEUTICALS, INC.
Date: April 5, 2006     By:   /s/ Maria S. Messinger
       

Maria S. Messinger

Vice President, Chief Financial Officer

and Corporate Secretary


EXHIBIT INDEX

 

Exhibit
Number
  

Description

99.1    Press Release of Cortex Pharmaceuticals, Inc. dated April 3, 2006.
EX-99.1 2 dex991.htm PRESS RELEASE OF CORTEX PHARMACEUTICALS, INC. Press Release of Cortex Pharmaceuticals, Inc.

Exhibit 99.1

LOGO

PRESS RELEASE

 

Contacts:   
Roger G. Stoll, Ph.D.    Damian R. McIntosh / Dian Griesel, Ph.D.
Chairman, President and CEO    Media Contact: Janet Vasquez
Cortex Pharmaceuticals, Inc.    The Investor Relations Group
(949) 727-3157    (212) 825-3210

CORTEX ANNOUNCES CLINICAL HOLD ON AMPAKINE® CX717

IRVINE, Calif., April 3, 2006 — Cortex Pharmaceuticals, Inc.’s (AMEX: COR), announced that it received a call from the U.S. Food and Drug Administration (“FDA”) on the afternoon of Friday, March 31 indicating that the FDA is placing CX717 clinical trials on hold. Cortex should receive formal written notification from the FDA within the next 7-10 days. The action taken by the FDA is related to concerns over some preclinical animal data and not to results from any human clinical trials. Until Cortex receives the formal notification and has had a chance to review its contents, it is unable to describe the exact terms of the notice. Cortex plans to cooperate fully with the FDA and request meetings with the FDA to clarify what must be done to resume clinical testing.

After Cortex receives the written notification from the FDA, has had a chance to analyze its contents, and has had discussions with the appropriate personnel within the agency, it plans to provide an update for shareholders and investors on this issue.

About Cortex Pharmaceuticals

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer’s disease and anxiety disorders. (http://www.cortexpharm.com/)


Forward-Looking Statement

Note – This press release contains forward-looking statements concerning the Company’s research and development activities. The success of such activities depends on a number of factors, including the risks that the Company’s proposed compounds may at any time be found to be unsafe or ineffective for the indications under clinical test and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.

#   #   #   #   #

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