FDA Rejects Grace Therapeutics Stroke Treatment
The FDA declined to approve GTx-104 for a rare type of stroke due to manufacturing and packaging data issues. Shares of Grace Therapeutics fell 43% today.
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Shares of GRACE THERAPEUTICS INC plummeted 43% on Thursday following a decision by the United States Food and Drug Administration (FDA) to decline approval for the company's lead drug candidate. The regulatory body issued a Complete Response Letter (CRL) regarding GTx-104, an injectable treatment designed for a rare and life-threatening form of stroke.
