Crinetics announces FDA acceptance of NDA for paltusotine in acromegaly; PDUFA Sept 25, 2025

Crinetics Pharmaceuticals, Inc.

FDA accepted Crinetics' NDA for once-daily oral paltusotine for adult acromegaly patients.
PDUFA target action date set for September 25, 2025; no advisory committee meeting planned.
NDA included Phase 3 PATHFNDR-1 and PATHFNDR-2 trials evaluating safety and efficacy.
Paltusotine granted Orphan Drug Designation by FDA in July 2020 for acromegaly.
If approved, paltusotine would be first once-daily oral SST2 nonpeptide agonist for acromegaly.

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