By Katherine Hamilton
Grace Therapeutics shares tumbled after regulators told the company that the application for its aneurysm treatment could not be approved in its current form.
The stock slid nearly 50%, to $2.21. Shares at one point during Thursday's session touched a 52-week low of $1.79. Year to date, shares have lost 40% of their value.
The Food and Drug Administration sent the biopharma company a Complete Response Letter for its GTx-104 treatment, which is designed to address medical needs in aneurysmal subarachnoid hemorrhage, a brain injury with a high death rate.
The FDA referenced certain items in the chemistry, manufacturing and controls, and non-clinical sections of the drug application that still need work. Grace said it believes it can address the issues in a resubmission of the application.
The flagged issues are related to leachables data for product packaging, non-clinical product toxicology risk assessments and product manufacturing deficiencies at the company's manufacturing site, the company said.
Grace plans to request a meeting with the FDA to clarify the path forward.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
April 23, 2026 14:56 ET (18:56 GMT)
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