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Tuesday, H.C. Wainwright adjusted its price target on shares of Black Diamond Therapeutics (NASDAQ:BDTX), increasing it to $12.00 from the previous $11.00, while reiterating a Buy rating on the stock. Currently trading at $1.71, the stock has experienced significant volatility, with a 64% decline over the past six months. According to InvestingPro data, analyst targets for the stock range from $9 to $20, suggesting substantial upside potential from current levels. The firm’s analysts highlighted upcoming catalysts for the company, specifically pointing to initial results for BDTX-1535 in the first-line (1L) setting for non-small cell lung cancer (NSCLC) patients with non-classical driver mutations expected in the second quarter of 2025. While the company maintains a strong financial position with a current ratio of 4.92 and more cash than debt on its balance sheet, InvestingPro analysis indicates the company is not yet profitable, with an EBITDA of -$75.5 million in the last twelve months. Further attention was drawn to updated Phase 2 results in the recurrent EGFR+ NSCLC setting anticipated in the second half of 2025.
Black Diamond (NASDAQ:CLAR) recently presented initial Phase 2 results for BDTX-1535, a fourth-generation, irreversible, brain-penetrant EGFR MasterKey inhibitor, in relapsed/refractory NSCLC patients with non-classical EGFR mutations and C797S resistance mutations. The treatment demonstrated a 36% objective response rate (ORR) in 22 response-evaluable patients, which improved to 42% after excluding patients without on-target resistance mutations. These findings were considered promising, with 74% of patients remaining on treatment as of the data cut, despite a relatively short follow-up period of 4.7 months.
The analysts at H.C. Wainwright noted the differences in patient populations when comparing BDTX-1535’s results with those of another candidate, firmonertinib, from ArriVent. They emphasized that unlike firmonertinib’s TKI-naive patient population, BDTX-1535’s study involved TKI-experienced patients.
Based on these encouraging preliminary results, Black Diamond is planning to move forward with a pivotal trial in the 1L setting and expects to provide more details in the latter half of 2025 after consulting with the FDA. The price target increase to $12 reflects a valuation update using a discounted cash flow (DCF) analysis, as H.C. Wainwright maintains a positive outlook on Black Diamond Therapeutics’ prospects. According to InvestingPro’s Fair Value analysis, the stock appears to be currently undervalued, with additional metrics and insights available to subscribers, including 8 more exclusive ProTips about the company’s financial health and market position.
In other recent news, Stifel analysts have adjusted their price target for Black Diamond Therapeutics to $15.00, down from the previous $16.00, while maintaining a Buy rating. This change comes as the company anticipates key data from a phase 2 cohort study of BDTX-1535, expected to be a significant milestone by the second quarter of 2025. The study, focusing on a first-line treatment for EGFRm NSCLC with non-classical mutations, involves approximately 20 patients and will be crucial for future regulatory discussions. Black Diamond Therapeutics plans to complete this cohort with a total of 40 patients by the end of the year and aims to start a pivotal trial in 2026.
In addition to the first-line cohort, the company has fully enrolled a second and third-line patient cohort, consisting of 83 patients with various mutations. Updated data for these cohorts are anticipated in the second half of 2025. Black Diamond is also exploring alternative business development opportunities to finance the trial, while maintaining cash guidance into the fourth quarter of 2026. Furthermore, the company has reintroduced the possibility of developing treatments for glioblastoma through an investigator-sponsored study, which will incur no additional costs.
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