---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-109644"
form_type: "8-K"
ticker: "CRNX"
cik: "0001658247"
company_name: "Crinetics Pharmaceuticals, Inc."
filed_at: "2024-09-26T23:59:59+00:00"
generated_at: "2026-05-31T01:34:54.002183+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-109644
- form_type: 8-K
- ticker: CRNX
- cik: 0001658247
- company_name: Crinetics Pharmaceuticals, Inc.
- filed_at: 2024-09-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658247/000095017024109644/0000950170-24-109644-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658247/000095017024109644/crnx-20240926.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-109644
- JSON: https://secwatch.observer/filing/0000950170-24-109644.json
- Plain text: https://secwatch.observer/filing/0000950170-24-109644.txt

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