---
schema_version: "secwatch.filing_event.v1"
accession: "0001711279-26-000064"
form_type: "8-K"
ticker: "KRYS"
cik: "0001711279"
company_name: "Krystal Biotech, Inc."
filed_at: "2026-10-15T11:02:30+00:00"
generated_at: "2026-10-15T11:05:09.175072+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Krystal Biotech KB113 pilot: 83% of BCC lesions regressed in 3 Gorlin syndrome patients

## Summary
- Over 80% of assessed landmark lesions regressed: 69/83 (83.1%) any regression; 42/83 (50.6%) >50% reduction; 8/83 (9.6%) at least 90% reduction.
- Substantial regression in non-injected lesions (40/47, 85.1%) suggests an abscopal effect; all three biopsied injected lesions showed histologically confirmed complete response.
- Three adults received six intralesional doses of up to 2 mL of 10^8 PFU/mL KB113 over 14 weeks; all 22 adverse events were mild/moderate and resolved, with no serious AEs.
- KB113 is the low dose of intratumoral KB707 from OPAL-1 (NCT05970497); Krystal has begun FDA discussions on advanced development for Gorlin syndrome.
- Data presented by investigator Dr. Shireen Guide at the 14th PeDRA Annual Conference, Oct 15-17, 2026; US Gorlin syndrome prevalence may exceed 10,000 patients.

## SEC filing metadata
- accession: 0001711279-26-000064
- form_type: 8-K
- ticker: KRYS
- cik: 0001711279
- company_name: Krystal Biotech, Inc.
- filed_at: 2026-10-15T11:02:30+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1711279/000171127926000064/0001711279-26-000064-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1711279/000171127926000064/krys-20261015.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001711279-26-000064
- JSON: https://secwatch.observer/filing/0001711279-26-000064.json
- Plain text: https://secwatch.observer/filing/0001711279-26-000064.txt

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