The Q4 2026 FDA feedback on silevertinib's pivotal path is the primary catalyst. Traders should watch for any pre-announcement or leaked data ahead of that timeline. The stock has historically sold off on positive news, so consider taking profits into any Q4 update rather than holding through.
Price Chart
Executive Summary
Black Diamond Therapeutics reported Q2 2026 results with a net loss of -$0.17 per share, slightly narrower than the -$0.19 loss in Q2 2025 and in line with the -$0.18 Street consensus. The company highlighted positive Phase 2 silevertinib data presented at ASCO, including a 60% ORR and 86% CNS ORR in frontline EGFRm NSCLC, and expects FDA feedback on a pivotal development path in Q4 2026.
Key Financial Metrics
Key Facts
- Net loss of $9.9M (-$0.17/share) for Q2 2026 vs -$10.6M (-$0.19/share) in Q2 2025, in line with Street consensus of -$0.18.
- Cash, cash equivalents, and investments at $110.5M as of June 30, 2026, sufficient to fund operations into 2H 2028.
- Phase 2 silevertinib data at ASCO showed 60% ORR, 86% CNS ORR, and median PFS of 15.2 months in frontline EGFRm NSCLC; no de novo brain metastases observed.
- Company expects FDA feedback on a pivotal development path for silevertinib in frontline NSCLC in Q4 2026.
- Net cash used in operations was $8.0M for Q2 2026, down from $9.2M in Q2 2025.
- R&D expenses decreased to $7.4M from $9.3M YoY; G&A expenses increased to $4.7M from $4.1M YoY.
Financial Impact
Net loss of $9.9M for Q2 2026, cash burn of $8.0M per quarter; cash runway into 2H 2028.
Risk Factors
- FDA feedback could be negative or require additional trials, delaying pivotal path.
- Competitive landscape includes osimertinib and other fourth-generation EGFR inhibitors.
- Cash runway into 2H 2028 provides buffer but may require dilutive financing if pivotal trial costs exceed expectations.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001701541-26-000023 |
| Document: bdtx-20260805.htm | 0001701541-26-000023 |
| Document: 0001701541-26-000023-index-headers.html | 0001701541-26-000023 |
| Document: 0001701541-26-000023-index.html | 0001701541-26-000023 |
| Document: 0001701541-26-000023.txt | 0001701541-26-000023 |
| 8-K Data (Synthetic) | 0001701541-26-000023 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 15, 2026 10w ago | Institutional Cluster | $2.05 $2.06 | ▲ +0.49% | ▲ +1.16% | $1.68 (−17.80%) |
Aug 5, 2026 11w ago | 8-K | $1.92 $1.95 | ▲ +1.56% | ▲ +0.95% | $1.68 (−12.24%) |
May 21, 2026 22w ago | 8-K | $2.28 $2.33 | ▲ +2.19% | ▲ +1.61% | $1.68 (−26.10%) |
May 21, 2026 22w ago | Press Release | $2.28 $2.33 | ▲ +2.19% | ▲ +1.61% | $1.68 (−26.10%) |
May 7, 2026 24w ago | 8-K | $2.72 $2.99 | ▲ +9.93% | ▲ +9.10% | $1.68 (−38.05%) |
Apr 21, 2026 27w ago | Press Release | $3.15 $3.35 | ▲ +6.35% | ▲ +5.33% | $1.68 (−46.51%) |
Mar 16, 2026 32w ago | Press Release | $2.23 $2.17 | ▼ −2.69% | ▼ −1.29% | $1.68 (−24.44%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers