Crinetics Pharmaceuticals, Inc. announced on December 9, 2024, that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for investigational candidate paltusotine. The NDA is for the treatment and long-term maintenance therapy of acromegaly in adults.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025, for completing the review of the NDA. The FDA also confirmed that an advisory committee meeting is not anticipated as part of the application's review process.
Paltusotine, if approved, would be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly. This acceptance marks a significant milestone, moving the company closer to a potential commercial launch and addressing an unmet need for an oral treatment option.
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