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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