---
schema_version: "secwatch.filing_event.v1"
accession: "0001534969-23-000121"
form_type: "8-K"
ticker: "SERA"
cik: "0001534969"
company_name: "SERA PROGNOSTICS, INC."
filed_at: "2023-12-06T23:59:59+00:00"
generated_at: "2026-06-07T17:03:55.104655+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Sera Prognostics PRIME study meets efficacy endpoint at interim; enrollment stopped

## Summary
- DSMB recommended stopping PRIME study enrollment after one co-primary endpoint met efficacy stopping criteria at interim.
- Company adopted DSMB recommendation; will stop enrollment to focus on analyzing and reporting available data.
- CEO Zhenya Lindgardt described early stop as 'unexpected' and 'encouraging,' citing consistency with prior PREVENT and AVERT studies.
- The PRIME trial is pivotal for the PreTRM® test, which aims to predict preterm birth risk.

## SEC filing metadata
- accession: 0001534969-23-000121
- form_type: 8-K
- ticker: SERA
- cik: 0001534969
- company_name: SERA PROGNOSTICS, INC.
- filed_at: 2023-12-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1534969/000153496923000121/0001534969-23-000121-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1534969/000153496923000121/sera-20231206.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001534969-23-000121
- JSON: https://secwatch.observer/filing/0001534969-23-000121.json
- Plain text: https://secwatch.observer/filing/0001534969-23-000121.txt

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