Flash FinanceUS
Market open S&P 5007,376.86+0.31% Nasdaq24,579.42+1.09% Dow 3051,285.73-0.46% Russell 20002,754.11+0.89% Nasdaq-10026,989.99+1.35% MidCap 4003,602.50+0.56% SmallCap 6001,673.98+0.05% VIX25.64-9.01% 10Y Yield4.86+0.45% Close of Nov 06, 2026
AI brief of an SEC Form 8-K · Black Diamond Therapeutics, Inc. (BDTX)

Black Diamond Therapeutics reports Phase 2 silevertinib data in frontline NSCLC with EGFR mutations

Positive Impact 3 of 5 product/contract Written later

Black Diamond Therapeutics reported preliminary Phase 2 results for silevertinib in 43 frontline non-small cell lung cancer patients with EGFR non-classical mutations, showing a preliminary median progression-free survival of 15.2 months. The company said the data support a 150 mg daily dose for pivotal development and plans to meet with the FDA later this year to discuss its pivotal plan. The results are early and the study remains ongoing, so they do not establish approval prospects.

Key points

  • Preliminary median progression-free survival of 15.2 months; median duration of response not reached
  • Objective response rate of 60% by RECIST 1.1 and CNS objective response rate of 86%; no patients developed new brain metastases
  • Treatment-related adverse events above Grade 3 fell to 28% after dose reduction; 150 mg daily supported for pivotal development
  • Data to be presented by Julia Rotow, M.D., at ASCO on May 30, 2026; company webcast on May 21, 2026 at 5:30 p.m. EDT

The filing

CompanyBlack Diamond Therapeutics, Inc. (BDTX)
Form8-K, current report
Filed with the SECMay 21, 2026, 5:19 PM ET
Accession number0001104659-26-065254

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on May 21, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.