---
schema_version: "secwatch.filing_event.v1"
accession: "0001658247-25-000008"
form_type: "8-K"
ticker: "CRNX"
cik: "0001658247"
company_name: "Crinetics Pharmaceuticals, Inc."
filed_at: "2025-09-26T23:59:59+00:00"
generated_at: "2026-05-17T05:34:12.137036+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Crinetics gets FDA approval for PALSONIFY (paltusotine) as first oral acromegaly treatment

## Summary
- FDA approved PALSONIFY (paltusotine) for adults with acromegaly with inadequate response to surgery or not surgical candidates.
- First once-daily oral SST2 agonist; approval based on Phase 3 PATHFNDR-1/2 trials showing rapid, durable biochemical control and reduced symptom burden.
- Product expected available in U.S. early October; CrinetiCARE support program launched for patients.
- MAA under review in EU (CHMP opinion H1 2026); also evaluating paltusotine in Phase 3 CAREFNDR trial for carcinoid syndrome.
- Investor conference call on Sept 25, 2025 at 6:00 pm ET to discuss FDA approval.

## SEC filing metadata
- accession: 0001658247-25-000008
- form_type: 8-K
- ticker: CRNX
- cik: 0001658247
- company_name: Crinetics Pharmaceuticals, Inc.
- filed_at: 2025-09-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658247/000165824725000008/0001658247-25-000008-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658247/000165824725000008/crnx-20250925.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001658247-25-000008
- JSON: https://secwatch.observer/filing/0001658247-25-000008.json
- Plain text: https://secwatch.observer/filing/0001658247-25-000008.txt

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