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FDA Lifts Cortex Trial Suspension

Irvine drug hopeful Cortex Pharmaceuticals Inc. said Monday that the Food and Drug Administration lifted a seven-month hold it placed on clinical trials for its Ampakine CX717 drug for possible memory enhancement.

Investors responded favorably, sending the Irvine drug maker’s shares up 9%. Cortex counts a market value of about $120 million.

Cortex now can restart clinical trials that were under way at the time regulators stepped in, citing concerns over animal test data.

The company said it committed to a FDA-specified dose for the trial. Cortex also said any testing at a higher dosage only would be done based on safety data from a three-month animal trial the drug maker expects to complete by the end of 2006.

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