---
schema_version: "secwatch.filing_event.v1"
accession: "0001599298-26-000006"
form_type: "8-K"
ticker: "SMMT"
cik: "0001599298"
company_name: "Summit Therapeutics Inc."
filed_at: "2026-01-29T23:59:59+00:00"
generated_at: "2026-05-16T06:26:46.311208+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Summit Therapeutics BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA; PDUFA Nov 14, 2026

## Summary
- FDA accepted BLA for ivonescimab + chemotherapy in EGFR-mutated non-squamous NSCLC post-TKI therapy.
- PDUFA goal action date set for November 14, 2026.
- BLA submission based on Phase III HARMONi trial results.
- Over 14,000 U.S. patients eligible for treatment annually in this setting.
- FDA plans full review including mid-cycle and wrap-up meetings before PDUFA date.

## SEC filing metadata
- accession: 0001599298-26-000006
- form_type: 8-K
- ticker: SMMT
- cik: 0001599298
- company_name: Summit Therapeutics Inc.
- filed_at: 2026-01-29T23:59:59+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/1599298/000159929826000006/0001599298-26-000006-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1599298/000159929826000006/smmt-20260129.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001599298-26-000006
- JSON: https://secwatch.observer/filing/0001599298-26-000006.json
- Plain text: https://secwatch.observer/filing/0001599298-26-000006.txt

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