Crinetics Pharmaceuticals, Inc. (CRNX) announced the FDA accepted its New Drug Application for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. The FDA has set a Prescription Drug User Fee target action date of September 25, 2025, for completing review of the NDA. The FDA confirmed that an advisory committee meeting is not anticipated as part of the applications review.
The company noted that the NDA submission for once-daily, oral paltusotine included data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 clinical trials.
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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.