BDTX 8-K SEC Filing Analysis

Latest settled — T+5d ⚠ clustered

BDTX ▼ -0.88% at T+5d

LONG call ✗ call lost -0.88% · α vs SPY -2.55% · entry $2.28 → $2.26

Next anchor: T+20d in 9d

Currently $1.75 · -23.25% from $2.28 entry

Entry anchored
May 21, 05:18 PM ET
via Databento tick

T+1d

+2.19%

call +2.19% · α +1.61%

$2.33

settled 22d ago

T+5d

-0.88%

call -0.88% · α -2.55%

$2.26

settled 15d ago

T+20d

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call — · α —

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in 9d

T+60d

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call — · α —

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in 2mo

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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.

Actionable Insight

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.

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

Exchange

Nasdaq

Sector

Biological Products, (No Diagnostic Substances)

Analyst Consensus

87% bullish (15 analysts)

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

5 reports for BDTX

T+1T+5T+20T+60

Track record builds as more directional reports settle.

Filters

Reports for BDTX — sortable, filterable
	Type				Now
May 21, 2026 22d ago	8-K BULLISH ★ 7/10	$2.28 $2.26	▼ −0.88%	▼ −2.55%	$1.75 (−23.25%)
May 21, 2026 22d ago	Press Release BULLISH ★ 8/10	$2.28 $2.26	▼ −0.88%	▼ −2.55%	$1.75 (−23.25%)
May 7, 2026 5w ago	8-K NEUTRAL ★ 4/10	$2.72 $2.86	▲ +5.15%	▲ +3.64%	$1.75 (−35.66%)
Apr 21, 2026 7w ago	Press Release BULLISH ★ 7/10	$3.15 $2.70	▼ −14.29%	▼ −15.37%	$1.75 (−44.44%)
Mar 16, 2026 12w ago	Press Release MIXED ★ 6/10	$2.23 $2.14	▼ −4.04%	▼ −1.38%	$1.75 (−21.52%)

US Market Status

Market Closed — Opens Mon (47h 34m)

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