Watch for FDA alignment update on KB113's clinical development plan, which could define the pivotal trial path and timeline for this new dermatology program. The abscopal effect data and histologically confirmed complete responses de-risk the mechanism, but the small sample size (n=3) warrants caution until larger studies confirm durability.
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Executive Summary
Krystal Biotech announced positive proof-of-concept clinical data for KB113, an intratumoral immunotherapy for basal cell carcinomas in Gorlin syndrome patients. Over 80% of assessed lesions regressed, with evidence of an abscopal effect and histologically confirmed complete responses in all three patients. The company has initiated FDA discussions to advance the program.
Key Facts
- Over 80% (69/83) of assessed landmark lesions regressed across three Gorlin syndrome patients treated with KB113
- 50.6% (42/83) of lesions demonstrated >50% clinical regression; 9.6% (8/83) showed ≥90% regression
- All three biopsied injected lesions with ≥90% regression showed histologically confirmed complete response
- Substantial regression observed in non-injected lesions, consistent with an abscopal effect
- All 22 reported adverse events were mild or moderate, transient, and resolved; no serious adverse events
- Company has initiated discussions with FDA regarding advanced clinical development of KB113
- Estimated US Gorlin syndrome prevalence could exceed 10,000 patients
Financial Impact
No financial data provided; early-stage clinical program with no revenue impact disclosed
Risk Factors
- Small sample size (n=3) — early pilot data may not predict later-stage results
- KB113 is investigational; safety and efficacy not yet established by FDA
- Regulatory pathway and timeline for Gorlin syndrome program are undefined pending FDA discussions
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001711279-26-000064 |
| Document: krystalgorlinprogramdataup.htm | 0001711279-26-000064 |
| Document: pedra2026gorlinfinaltopr.htm | 0001711279-26-000064 |
| Document: 0001711279-26-000064-index-headers.html | 0001711279-26-000064 |
| Document: 0001711279-26-000064-index.html | 0001711279-26-000064 |
| Document: 0001711279-26-000064.txt | 0001711279-26-000064 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | Institutional Cluster | $311.52 | awaiting T+20 | — | $320.58 (+2.91%) |
Oct 27, 2026 today | SC 13G/A | $311.52 | awaiting T+20 | — | $320.58 (+2.91%) |
Oct 22, 2026 5d ago | Press Release | $320.13 | awaiting T+20 | — | $320.58 (+0.14%) |
Oct 21, 2026 6d ago | Institutional Cluster | $320.13 | awaiting T+20 | — | $320.58 (+0.14%) |
Oct 15, 2026 12d ago | 8-K | $330.00 | awaiting T+20 | — | $320.58 (−2.85%) |
Sep 4, 2026 7w ago | Insider Cluster | $351.26 $326.81 | ▲ +6.96% | ▲ +8.67% | $320.58 (+8.73%) |
Aug 14, 2026 10w ago | 144 | $335.73 $336.68 | ▲ +0.28% | ▲ +2.26% | $320.58 (−4.51%) |
Aug 3, 2026 12w ago | 8-K | $312.57 $359.36 | ▲ +14.97% | ▲ +13.73% | $320.58 (+2.56%) |
Jul 23, 2026 13w ago | Press Release | $335.19 $346.58 | ▲ +3.40% | ▼ −0.23% | $320.58 (−4.36%) |
Jun 5, 2026 20w ago | Insider Cluster | $301.76 $374.68 | ▲ +24.16% | ▲ +22.53% | $320.58 (+6.24%) |
US Market Status
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