The strong Phase 2 data, especially CNS activity and mPFS, position silevertinib as a potential frontline therapy. Watch for FDA meeting later this year and ASCO presentation on May 30, 2026. Positive data could accelerate partnership or financing interest.
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Executive Summary
Black Diamond Therapeutics reported positive Phase 2 results for silevertinib in frontline NSCLC patients with EGFR non-classical mutations. Key data include preliminary median PFS of 15.2 months, 60% ORR, 86% CNS ORR with no de novo brain metastases, and a manageable safety profile. The company plans to meet with the FDA later this year to discuss a pivotal development path.
Key Facts
- Preliminary median progression-free survival (mPFS) of 15.2 months (95% CI: 10.8, NE)
- Median duration of response (DOR) not reached (95% CI: 7.0, NE)
- Objective response rate (ORR) of 60% and disease control rate (DCR) of 91%
- CNS ORR of 86% by RANO-BM; no patients developed de novo brain metastases
- 23 of 43 patients (53%) remain on therapy; longest treatment duration 23.5 months
- No new safety signals; TRAEs > Grade 3 reduced to 28% after dose reduction
- Safety and efficacy data support 150 mg QD dose for pivotal development
- Company to meet with FDA later this year to discuss pivotal plan
Financial Impact
No financial data in filing; pre-revenue clinical-stage biotech. Catalyst for stock based on efficacy/safety data.
Risk Factors
- Phase 2 data are preliminary; larger pivotal trials needed
- Clinical failure or safety issues in larger trials
- Competition from other EGFR TKIs for non-classical mutations
- Regulatory delays or requirement for additional data
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-065254 |
| Document: tm2615293d1_ex99-1.htm | 0001104659-26-065254 |
| Document: 0001104659-26-065254-index-headers.html | 0001104659-26-065254 |
| Document: 0001104659-26-065254-index.html | 0001104659-26-065254 |
| Document: 0001104659-26-065254.txt | 0001104659-26-065254 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 15, 2026 10w ago | Institutional Cluster | $2.05 $2.06 | ▲ +0.49% | ▲ +1.16% | $1.76 (−13.90%) |
Aug 5, 2026 11w ago | 8-K | $1.92 $1.95 | ▲ +1.56% | ▲ +0.95% | $1.76 (−8.07%) |
May 21, 2026 22w ago | 8-K | $2.28 $2.33 | ▲ +2.19% | ▲ +1.61% | $1.76 (−22.59%) |
May 21, 2026 22w ago | Press Release | $2.28 $2.33 | ▲ +2.19% | ▲ +1.61% | $1.76 (−22.59%) |
May 7, 2026 24w ago | 8-K | $2.72 $2.99 | ▲ +9.93% | ▲ +9.10% | $1.76 (−35.11%) |
Apr 21, 2026 26w ago | Press Release | $3.15 $3.35 | ▲ +6.35% | ▲ +5.33% | $1.76 (−43.97%) |
Mar 16, 2026 31w ago | Press Release | $2.23 $2.17 | ▼ −2.69% | ▼ −1.29% | $1.76 (−20.85%) |
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