Crinetics submits NDA to FDA for paltusotine for acromegaly; Phase 3 data support submission

Crinetics Pharmaceuticals, Inc.

NDA supported by 18 clinical trials including two Phase 3 PATHFNDR studies; all primary and secondary endpoints met.
FDA notification on NDA acceptance expected in December 2024.
Paltusotine is first once-daily oral SST2 nonpeptide agonist in development for acromegaly.
Drug also in Phase 2 for carcinoid syndrome associated with neuroendocrine tumors.
CEO states submission is a key step toward delivering a new therapy for the acromegaly community.

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