The LPLV milestone de-risks the trial timeline but provides no efficacy data. The binary catalyst is the top-line readout in ~2 months — monitor for any pre-readout data safety monitoring board updates or early unblinding announcements.
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Executive Summary
Sol-Gel Technologies announced last patient last visit (LPLV) in its pivotal Phase 3 trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, with top-line results on track for late November 2026. This is a binary catalyst milestone — the stock will swing on the primary endpoint readout in ~2 months.
Key Facts
- Last patient completed the last scheduled study visit in the pivotal Phase 3 trial (SGT-610-01) of SGT-610 (patidegib gel, 2%) for Gorlin syndrome.
- Top-line results remain on track for late November 2026.
- The randomized, double-blind, vehicle-controlled Phase 3 study enrolled 113 patients with Gorlin syndrome, of whom 102 completed the study.
- Primary endpoint: number of new BCCs on the face at month 12 after twice daily treatment.
- SGT-610 has orphan drug and breakthrough therapy designations from the FDA.
Financial Impact
No financial data in filing. Stock price impact will be determined by the Phase 3 primary endpoint readout in late November 2026.
Risk Factors
- Phase 3 trial may fail to meet its primary endpoint (number of new BCCs on the face at month 12).
- Small sample size (113 enrolled, 102 completed) increases statistical variability risk.
- Company has a history of recurring losses and may need additional financing before potential approval.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001178913-26-004537 |
| Document: zk2636127.htm | 0001178913-26-004537 |
| Document: 0001178913-26-004537-index-headers.html | 0001178913-26-004537 |
| Document: 0001178913-26-004537-index.html | 0001178913-26-004537 |
| Document: 0001178913-26-004537.txt | 0001178913-26-004537 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 6, 2026 20d ago | 6-K | $75.64 | awaiting T+20 | — | $69.45 (−8.18%) |
Sep 30, 2026 26d ago | 6-K | $74.28 | awaiting T+20 | — | $69.45 (−6.50%) |
Sep 17, 2026 5w ago | 6-K | $64.54 $68.70 | ▲ +6.45% | ▲ +4.99% | $69.45 (+7.61%) |
Sep 14, 2026 6w ago | Insider Buy | $64.40 $68.30 | ▲ +6.06% | ▲ +3.08% | $69.45 (+7.84%) |
Sep 9, 2026 6w ago | Insider Buy | $66.79 $70.34 | ▲ +5.32% | ▲ +2.94% | $69.45 (+3.98%) |
Sep 3, 2026 7w ago | Insider Buy | $69.52 $78.95 | ▲ +13.56% | ▲ +12.96% | $69.45 (−0.10%) |
Aug 31, 2026 8w ago | Insider Buy | $69.52 $74.28 | ▲ +6.85% | ▲ +6.53% | $69.45 (−0.10%) |
Aug 20, 2026 9w ago | 6-K | $78.50 $64.54 | ▼ −17.78% | ▼ −17.78% | $69.45 (−11.52%) |
Aug 20, 2026 9w ago | Press Release | $78.50 $64.54 | ▼ −17.78% | ▼ −17.78% | $69.45 (−11.52%) |
Aug 14, 2026 10w ago | Insider Buy | $83.01 $64.40 | ▼ −22.42% | ▼ −20.44% | $69.45 (−16.34%) |
US Market Status
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