Cortex Pharmaceuticals Submits Research Plan to Remove FDA Clinical Hold on Drug Candidate IRVINE, Calif. -- Cortex Pharmaceuticals Inc. said Tuesday it has provided the Food and Drug Administration with a preclinical research plan to remove the agency's clinical hold on its flagship drug.

In April, the FDA placed a hold on the company's clinical trials of CX717, a drug candidate being tested to treat diseases such as Alzheimer's and anxiety disorders, over concerns about data from animal tests.

The company said the FDA found the proposed research plan acceptable, added that it plans to submit all the data to the agency in September.

Cortex says it believes that if the data obtained from high-dose toxicology studies of the drug are assessed positively by the FDA, the FDA will remove the clinical hold on CX717.

Shares rose 53 cents, or 17.9 percent, to $3.50 in morning trading on the American Stock Exchange. In the past 52 weeks, the stock has traded between $2.02 and $5.94.