Crinetics Pharmaceuticals (CRNX) said Monday that the US Food and Drug Administration had accepted its New Drug Application for paltusotine to treat acromegaly in adults.
The FDA has set Sept. 25, 2025 as the target action date for the Prescription Drug User Fee Act, Crinetics said.
Acromegaly is a rare disease generally caused by a benign pituitary tumor that secretes excess growth hormone, the company said.
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