COR

[Terliso]

We've got news from COR


Cortex' CX717 Released from Clinical Hold by FDA
Monday October 9, 8:30 am ET

IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (AMEX:COR - News) received notification from the U.S. Food and Drug Administration (FDA) on the afternoon of Friday, October 6, 2006 that the clinical hold placed on its AMPAKINE® CX717 on March 31, 2006 was lifted. The Company may now resume the clinical trials that were underway at the time the clinical hold was put into effect. A detailed formal letter from the FDA is expected to follow within 10 days.

In agreeing to the lifting of the hold, Cortex committed to an FDA specified dose range for CX717. The Company expects to have further toxicological information available toward the end of this year, after completion of three-month toxicology trials in both monkeys and rats. The Company will then share those results with the FDA and mutually determine if the new information supports clinical investigations at higher dosage levels for CX717.

Roger Stoll, Ph.D., Chief Executive Officer of Cortex, commented, "The release from clinical hold is an important step for Cortex and the CX717 clinical program. It is fortunate that the Company had the foresight to initiate the three-month toxicology trials early this summer, so that we can have further information from these studies available before year end 2006."

After receiving the formal letter from the FDA regarding the lifting of the clinical hold, the Company will hold a conference call to update shareholders on the next steps with the CX717 program.

[Terliso]

Looks like another black candle will print on COR this session
.......MACD fast line crossed above slow line today

[tokyopua]

COR woke up BIGGGG time today, huge volume, island reversal 

http://stockcharts.com/h-sc/ui?s=COR&p=D&b=5&g=0&id=p88143174889

The FDA had them on hold, then they came off hold but could only use small dosages for their tests, now it appears that is going to be lifted.

http://www.wsw.com/webcast/roth9/cor/

I am thinking of holding till it goes to the gap, not sure.  Got in at 1.4 and it closed with some big volume and big blocks right at the close that then dissappeared from my screen on Etrade.  And this volume today was bigger than the drop from $3 recently, so that is a sign it can run further, too.

Thanks to Rudynostalgia for pointing this one out today!

[tokyopua]

Here is the chart:

[tokyopua]

News out, holy smoke pre market is 1.91, guess this thing is going to gap up 

--------------------------
IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (AMEX: COR - News), presenting at the 19th Annual Roth Capital Partners Growth Stock Conference on Wednesday, February 21st, reported that it had generated data which indicated that the histopathological changes previously reported for its lead AMPAKINE® product candidate, CX717, occurred postmortem in the animal tissue. If similar tissue was rapidly removed from animals and placed in an appropriate buffered medium, the tissue showed no signs of any histopathological changes and was physiologically normal.

After earlier preclinical histopathological tissue results were reviewed by the FDA, the agency initiated a clinical hold for CX717 in March 2006. At the request of the FDA, Cortex conducted extensive additional animal toxicology studies during the summer of 2006 and in October 2006 the agency lifted the clinical hold, but placed significant dosage limitations on the use of CX717 in clinical trials. These limitations meant that Cortex could not proceed with further clinical assessments of CX717 in ADHD patients. CX717 had earlier demonstrated positive results in a pilot ADHD study in adult patients in a pilot Phase IIa study in March 2006. Cortex is planning to submit this new preclinical data to the FDA in March with a request to have the dosage limitations changed so that it can proceed to conduct further clinical trials of CX717 in adult ADHD patients. Dr. Stoll, the Chief Executive Officer of Cortex, cautioned that the final decision on the adequacy of the data to allow the Company to proceed clinically is up to the FDA.

Dr. Stoll also mentioned during his presentation that the FDA had just issued a notice that will require that all current manufacturers of ADHD drugs issue Patient Medication Guides that spell out the risks of the current medications with respect to cardiovascular and psychiatric adverse events observed with the currently approved therapies. Dr. Stoll noted that the potential for a new therapeutic approach to the treatment of ADHD is clear and, if clinically safe and effective, CX717 could meet many of the current market needs. Dr. Stoll reiterated that the 3-week study in adult ADHD patients randomized to either CX717 or placebo, in a cross-over design, was both clinically and statistically significant on both decreasing hyperactivity and increasing attention on the primary ADHD rating scale which is the primary measure by which all ADHD products are approved.

Another point made by Dr. Stoll during the presentation at the Roth Conference was that the most recent studies by Dr. Gary Lynch at UC Irvine using a high impact AMPAKINE drug, CX929, showed very encouraging results in transgenic mice with the Huntington's Disease gene. CX929 not only returned depressed levels of BDNF (brain derived neurotrophic factor) back to normal, restored long term potentiation and most recently showed significant improvements in behavioral effects in the transgenic mouse model.

The remaining topics covered by Dr. Stoll included an update on the low-impact AMPAKINE CX701 which Cortex anticipates commencing clinical trials by July 2007, the likelihood of a new research and development collaboration for its high-impact AMPAKINE compounds, and the in-licensing of a new Phase II non- AMPAKINE orphan drug.

A replay of the presentation will be available for 30 days and can be accessed via the following link: http://www.wsw.com/webcast/roth9/cor/.

More information regarding the conference can be found at http://www.rothconference.com/.

About Cortex

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. For additional information regarding Cortex, please visit Cortex Pharmaceuticals' Website at www.cortexpharm.com.

NOTE -- THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WITH RESPECT TO FUTURE REGULATORY ACTIONS BY THE FDA, INTERPRETATIONS OF PRE-CLINICAL TOXICOLOGY RESULTS AND ANTICIPATED RESULTS OF FUTURE CLINICAL TRIALS AND THE POSSIBLE CLINICAL USES OF AMPAKINE COMPOUNDS, ALL OF WHICH ARE DIFFICULT OR IMPOSSIBLE TO PREDICT ACCURATELY AND MANY OF WHICH ARE BEYOND THE CONTROL OF CORTEX, ALL AS MORE FULLY DESCRIBED IN THE RISK FACTORS AND OTHER MATTERS SET FORTH IN CORTEX'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2005, AND CORTEX'S OTHER FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. CORTEX DISCLAIMS ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS.



Contact:
Cortex Pharmaceuticals, Inc.
Roger G. Stoll, Ph.D., Chairman, President and CEO
949-727-3157
or
The Investor Relations Group
Investors:
Erika Moran/Dian Griesel, Ph.D., 212-825-3210
or
Media:
Janet Vasquez/Lynn Granito, 212-825-3210

[tokyopua]

Guess I am going to play this rebound alone eh 

Anyway, COR now looking like a breakaway gap, a convincing break of 1.98 resistance puts 2.27 squarely in play.  At 1.90 now.

[makingmoney]

I am playing this one too. The Roth presentation is a sentiment changing event. it is positive now. let's see how high can it go. thinking $3.

[dnickers]

Hey Tokyopua - I'm in on this one too.  Got in a little bit after you at 1.63.  Looking forward to see what Monday brings...

[tokyopua]

Hey Tokyopua - I'm in on this one too.  Got in a little bit after you at 1.63.  Looking forward to see what Monday brings...

Good to see I am not in this alone.  I am trying to figure out if the gap might fill, but the volume is so explosive it seems it may not.  The weekly volume matched the largest volume back from April 3, but that week the news started on a Monday, so its clear that the volume here is more significant.  Also, there has never been so much volume in 2 days before.  I think if we break the HOD 1.98 from Friday then this baby can rocket up.

[tokyopua]

Hey Tokyopua - I'm in on this one too.  Got in a little bit after you at 1.63.  Looking forward to see what Monday brings...

Good to see I am not in this alone.  I am trying to figure out if the gap might fill, but the volume is so explosive it seems it may not.  The weekly volume matched the largest volume back from April 3, but that week the news started on a Monday, so its clear that the volume here is more significant.  Also, there has never been so much volume in 2 days before.  I think if we break the HOD 1.98 from Friday then this baby can rocket up.

I sold this one during the selloff unfortunately, but got back in today at 2.31, they announced the news that everyone had been waiting for:

Submitted to FDA

  Data Demonstrates that Specific Histopathological Changes Found in

            Animal Toxicology Studies Occurred Postmortem
IRVINE, Calif.--(BUSINESS WIRE)--April 18, 2007--

  Cortex Pharmaceuticals, Inc. (AMEX: COR), sent two large data packages to the
Food & Drug Administration (FDA) today regarding the Company's lead Phase II
AMPAKINE(R) product candidate, CX717. One data set went to the FDA's Division
of Neurology Drug Products and the other went to the Division of Psychiatry
Products. The original CX717 Investigational New Drug (IND) was filed with
Neuropharmacological Division (now Neurology Division) for the treatment of
Alzheimer's disease (AD) and the other data package went to the Psychiatry
Division, where the Company intends to file a second CX717 IND for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD). The submitted
data package provides clear evidence that the specific histopathological
changes seen in animal toxicology studies, which previously caused the FDA to
put CX717 on clinical hold, is a postmortem fixation artifact and is not found
in the tissue of the animal when it is still living.


  Dr. Roger Stoll, Chief Executive Officer of Cortex, stated, "When CX717 was
removed from clinical hold on October 6, 2006 by the Neurology Division a dose
was permitted for continuing a study in patients with AD, but that dose was too
low to permit the assessment of the drug in patients with ADHD. Further
information was needed to better understand the cause of the histopathological
changes." Dr. Stoll added that, "We now have a substantial data base which
clearly documents the fact that the histological changes of concern occur
postmortem when the fixative solution is used to prepare the slides of the
tissue specimens."


  In early March 2006 Cortex reported in a small pilot Phase II study, that
CX717 had demonstrated positive clinical and statistical results on the primary
endpoint, the ADHD rating scale and the sub-scales related to attention and
hyperactivity which are used for the approval of all currently available ADHD
treatments. Consistent with all previous studies involving over 220 patients
and healthy adults, this study demonstrated that CX717 was safe, well
tolerated, and produced no increase in heart rate, blood pressure or other
cardiovascular side effects. Cortex intends to cooperate fully with the FDA and
the Company must now wait to hear from the agency regarding their willingness
to approve higher dose levels for studying CX717 in adults with ADHD, and the
Company's subsequent desire to proceed with a larger Phase IIb study for this
indication.

   About Cortex


  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(R) 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. For additional information regarding
Cortex, please visit Cortex Pharmaceuticals' Website at www.cortexpharm.com.


  NOTE -- THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WITH RESPECT
TO FUTURE REGULATORY ACTIONS BY THE FDA, INTERPRETATIONS OF PRE-CLINICAL
TOXICOLOGY RESULTS AND ANTICIPATED RESULTS OF FUTURE CLINICAL TRIALS AND THE
POSSIBLE CLINICAL USES OF AMPAKINE COMPOUNDS, ALL OF WHICH ARE DIFFICULT OR
IMPOSSIBLE TO PREDICT ACCURATELY AND MANY OF WHICH ARE BEYOND THE CONTROL OF
CORTEX, ALL AS MORE FULLY DESCRIBED IN THE RISK FACTORS AND OTHER MATTERS SET
FORTH IN CORTEX'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31,
2006, AND CORTEX'S OTHER FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION.
CORTEX DISCLAIMS ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING
STATEMENTS.

    CONTACT: Cortex Pharmaceuticals, Inc.
             Roger G. Stoll, Ph.D., 949-727-3157
             Chairman, President and CEO
             or
             Investors:
             The Investor Relations Group
             Erika Moran/ Dian Griesel, Ph.D., 212-825-3210

    SOURCE: Cortex Pharmaceuticals, Inc.
Copyright Business Wire 2007


  (END) Dow Jones Newswires

  04-18-07 0833ET

08:33 041807

[setravis]

AP
Cortex to Resume Alzheimer's Study
Tuesday July 17, 9:22 am ET 
Cortex Pharmaceuticals to Resume Alzheimer's Disease Study for Drug Candidate CX717


IRVINE, Calif. (AP) -- Drug developer Cortex Pharmaceuticals Inc. said Tuesday it will resume a study of its lead compound CX717 in Alzheimer's disease patients after getting clearance from the Food and Drug Administration.


In April 2006, the FDA put clinical trials of the compound on hold over concerns from animal test results. The drug is also being studied in narcolepsy, attention deficit hyperactivity disorder and schizophrenia. The Ampakine compounds aim to strengthen signals between brain cells.

The Alzheimer's study was originally designed to involve 200-milligram, 600-milligram and 1,200-milligram doses, with the latter two being suspended. The study will return to all three dose levels.

The company said it plans to ask the FDA during the third quarter to approve a Phase IIb study of CX717 in attention deficit hyperactivity disorder.

Shares of Cortex rose 62 cents, or 23.2 percent, to $3.29 in premarket trading, from their close at $2.67 Monday.

Questions or comments about this story should be directed to Damian J. Troise at 212-621-7593

[setravis]

July 17 (Reuters) - Cortex Pharmaceuticals Inc. (COR,Trade) said it has received approval from U.S. regulators to resume enrollment for clinical trials of its drug candidate, Ampakine CX717, in Alzheimer PET-scan studies .

The trial will resume at all dose levels.

The study of Ampakine CX717, which was originally designed with doses of 200mg, 600mg and 1200mg, was placed on hold by the U.S. Food and Drug Administration due to concerns over some preclinical animal data. (Reporting by Shailesh Kuber in Bangalore)


52wk Range: 1.02 - 3.81
Volume: 1,564,600
Avg Vol (3m): 234,838

Technicals
13-day MA Cross Below 50-day MA
Most Actives
Gap Up
Percentage Gainer

Last Price Quote is:
25.57%above 13-day MA
25.50%above 50-day MA
RS Rating: 89 

Fundamentals
Key Data:
Market Cap (M): N/A 
P/E Ratio: N/A 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Mkt Outperform