Grace Therapeutics (GRCE) announced that on August 22, 2025 the FDA accepted the New Drug Application for GTx-104 for formal review. The application seeks approval for GTx-104 for the treatment of patients with aSAH. The FDA established a PDUFA target date of April 23, 2026 for its review of the NDA submission.
Grace Therapeutics noted that the acceptance of the NDA for review triggers the potential exercise of up to $7.6 million in warrants issued as part of a private placement the company completed in September 2023.
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Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.