CytRx Expects To File FDA Response In 4Q
LOS ANGELES (AP) ¿ Biotechnology company CytRx Corp. said Tuesday it expects to respond to a Food and Drug Administration request for more information on a potential Lou Gehrig's disease treatment during the fourth quarter.
In January, the FDA suspended a midstage study of the experimental drug arimoclomol citing the need for additional analysis. CyRtx said it will send its revised trial design to the FDA during the fourth quarter. If it is accepted, the company will be able to restart midstage development on the drug, potentially during the same quarter.
Lou Gehrig's disease, a progressive condition that affects nerve cells in the brain and spinal cord, currently has no cure or treatment that halts or reverses the condition.
Shares of CytRx rose 4 cents to close Tuesday's regular session at $1.01. The stock has traded between 23 cents and $1.72 over the last 52 weeks.(This version edits 2nd graf to clarify that CytRx is not submitting additional trial data to the FDA, but rather an amended study protocol.)
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