secwatch.observer — SEC 8-K summary
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Issuer:     Krystal Biotech, Inc. (KRYS)
CIK:        0001711279
Form:       8-K
Filed at:   2026-01-08T23:59:59+00:00
Accession:  0001711279-26-000005
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Krystal Biotech KB407 Phase 1 positive: CFTR delivery confirmed in all 6 biopsied patients
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- Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations (modulator ineligible).
- Transduction rates ranged 29.4% to 42.1% across six patients; all biopsies positive for CFTR or viral marker.
- KB407 well tolerated; one SAE (asthma exacerbation) deemed procedure-related, resolved in 5 days.
- Registrational CORAL-3 study design submitted to FDA; enrollment expected 1H 2026 after alignment.
- Four of seven highest-dose patients were modulator ineligible; data supports mutation-agnostic potential.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711279/000171127926000005/0001711279-26-000005-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711279/000171127926000005/krys-20260108.htm
  HTML page:      https://secwatch.observer/filing/0001711279-26-000005

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