Silevertinib Phase 2 Data Shows 15.2-Month mPFS in NSCLC, Exceeding Historical Therapies
BDTX sits 69% above its 52-week low of $1.93 on elevated volume (5.1× avg).
Summary
Black Diamond Therapeutics announced positive Phase 2 results for silevertinib in frontline NSCLC patients with EGFR non-classical mutations, reporting a preliminary median Progression-free Survival (mPFS) of 15.2 months. This strong clinical update follows the company's Q1 2026 report which highlighted a net loss and a reduced cash runway, making pipeline progress critical. The mPFS data is stated to "far exceed historical data for currently available therapies" and the drug also prevented de novo brain metastases, addressing a significant unmet need. These results are crucial for a small-cap biotech and could significantly improve its outlook and financing prospects. The company plans to meet with the FDA later this year to discuss pivotal development, and the full data will be presented at the ASCO Annual Meeting on May 30, 2026.
At the time of this announcement, BDTX was trading at $3.27 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $203.4M. The 52-week trading range was $1.93 to $4.94. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.