secwatch.observer — SEC 8-K summary
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Issuer:     Crinetics Pharmaceuticals, Inc. (CRNX)
CIK:        0001658247
Form:       8-K
Filed at:   2023-09-11T23:59:59+00:00
Accession:  0001193125-23-231899
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Crinetics' oral paltusotine succeeds in Phase 3 PATHFNDR-1; 83% maintain IGF-1 vs 4% on placebo
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- Paltusotine met primary endpoint: 83% maintained IGF-1 ≤1.0xULN vs 4% on placebo (p<0.0001).
- All secondary endpoints met, including GH <1.0 ng/mL (87% vs 28%, p=0.0003) and symptom diary scores.
- No serious or severe adverse events; AE frequency 80% paltusotine vs 100% placebo, fewer acromegaly-related events.
- PATHFNDR-2 (untreated patients) topline data expected Q1 2024; NDA submission planned for 2024.
- Phase 2 study in carcinoid syndrome interim results expected later 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1658247/000119312523231899/0001193125-23-231899-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1658247/000119312523231899/d657121d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-231899

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer