---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-134342"
form_type: "8-K"
ticker: "CRNX"
cik: "0001658247"
company_name: "Crinetics Pharmaceuticals, Inc."
filed_at: "2024-12-09T23:59:59+00:00"
generated_at: "2026-05-29T05:40:59.497619+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-134342
- form_type: 8-K
- ticker: CRNX
- cik: 0001658247
- company_name: Crinetics Pharmaceuticals, Inc.
- filed_at: 2024-12-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658247/000095017024134342/0000950170-24-134342-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658247/000095017024134342/crnx-20241209.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-134342
- JSON: https://secwatch.observer/filing/0000950170-24-134342.json
- Plain text: https://secwatch.observer/filing/0000950170-24-134342.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.