Black Diamond Stock Surges on Promising Lung Cancer Drug Data
Silevertinib shows high response rates, especially in brain metastases, prompting the company to launch a new trial for the aggressive brain cancer glioblastoma.
Shares of Black Diamond Therapeutics (NASDAQ: BDTX) soared in morning trading after the company announced positive preliminary Phase 2 data for its experimental cancer drug, silevertinib, in patients with a specific form of non-small cell lung cancer (NSCLC).
The Cambridge-based biotechnology firm reported that its precision therapy demonstrated robust anti-tumor activity in 43 patients. According to the company's press release, the drug achieved an overall response rate (ORR) of 60% in frontline NSCLC patients whose tumors harbor non-classical EGFR mutations, a challenging-to-treat genetic profile.
Perhaps most significantly, the study revealed an 86% central nervous system (CNS) response rate, indicating the drug is highly effective against cancer that has spread to the brain. Treating brain metastases is a critical challenge in oncology, and this potent CNS activity represents a key potential differentiator for silevertinib.
“We are particularly encouraged by the CNS activity of silevertinib in treating NSCLC patients with brain metastases,” said Mark Velleca, M.D., Ph.D., President and CEO of Black Diamond Therapeutics. “We are struck by the compelling CNS response rate, which may translate to prolonged durability of response for patients with CNS metastases,” added Sergey Yurasov, M.D., Ph.D., the company's Chief Medical Officer.
Investors reacted with enthusiasm to the data, driving the stock up sharply and reversing a sell-off from the previous session. The news provides a significant clinical proof-of-concept for Black Diamond's approach, which focuses on developing therapies for genetically defined cancers.
Buoyed by the strong CNS results, Black Diamond also announced plans to expand silevertinib's development into a new and notoriously difficult-to-treat cancer: glioblastoma (GBM). The company intends to initiate a randomized Phase 2 trial in newly diagnosed GBM patients in the first half of 2026. Approximately half of all GBM patients have an oncogenic EGFR alteration that could be targeted by the drug.
“Prior attempts to treat EGFR-altered GBM patients have been limited by poor brain penetrance of targeted therapies,” noted Elizabeth Buck, Ph.D., Chief Scientific Officer. “Based on encouraging CNS activity demonstrated by silevertinib across multiple trials... we believe that silevertinib has the potential to be the first targeted therapy for these patients.”
Wall Street analysts have maintained a bullish outlook on the company, with a consensus "strong buy" rating and price targets ranging as high as $11, according to recent reports. The positive data is likely to reinforce this conviction, as the company now has a clearer path forward in NSCLC and a new, high-impact opportunity in GBM.
The company’s strategy involves seeking a partner for the costly pivotal development of silevertinib in the broader lung cancer market while independently funding the more focused GBM trial. Black Diamond reported having approximately $135.5 million in cash and investments as of September 30, 2025, which it projects will fund operations into the second half of 2028.
Investors will be watching for the next major catalysts, including the full data set from the NSCLC trial, with duration of response and progression-free survival metrics expected in the second quarter of 2026.